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Indivior jobs

- 22 jobs
  • Account Director (California)

    Indivior 4.8company rating

    Remote Indivior job

    TITLE: Account Director (California) Title: Account Director Reports To: Commercial Head Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: The Account Director will lead the strategy within California across the United States. They will develop relationships with the assigned accounts and with key decision makers to represent the interests of Indivior and its entire portfolio. They will also support Indivior by identifying and then developing new business opportunities in collaboration with the account or its affiliates, work closely with our sales stakeholders to evaluate and determine if local, regional, and national opportunities can and should be expanded system-wide to drive business results, within assigned accounts. The incumbent will also be required to effectively serve as an internal advocate for assigned account issues and priorities. This position is field based. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: · Field based interaction with assigned institutional and/or integrated key accounts · Coordinate efforts with existing Organized Health System, Key Accounts, and Sales teams · Develop and implement comprehensive business plans for assigned accounts to ensure targeted growth of Indivior portfolio · Develop and maintain collaborative working relationships with external stakeholder decision makers and account influencers within assigned accounts · Collaborate with Medical Affairs to ensure fair balanced delivery of all product value proposition presentations, clinical proofs, economic models, tools and other value add services are fully leveraged within assigned accounts · Accountable for achieving access, and outcome goals as agreed upon and identified in account generated business plans · Develop trusting and collaborative relationships with business unit Sales/Marketing · Leadership, Strategy, Value, Access Team, Legal, Finance and other internal colleagues to execute on identified customer business plans · Assist our sales organizations in driving sales and/or market share results synchronized with field sales performance goals, by clearly outlining and agreeing to appropriate pull-through opportunities with sales and market access leadership · Identify and deliver on account point of view and priorities as part of market research, marketing planning and other internal planning processes · Ensure that all activities and interactions are carried out with the highest ethical and professional standards and that all work is accomplished with integrity and in accordance with Indivior Core Values · Assist with implementation of formulary placement at the regional and local facility level · Carry out other reasonable tasks as required by Market Access Leadership. The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements MINIMUM QUALIFICATIONS: · BS/BA degree from a four-year accredited university or college; Business/Finance degree desired · Minimum of 5 years in field sales with a pharmaceutical, medical device or specialty pharmaceutical company · Minimum of 5 years as customer facing account director role (hospital, payer, professional organization) · Experience working with large health systems central contracting process · Well-developed relationships with key decision makers and a thorough understanding of the potential assigned accounts · Proficient Microsoft Office Suite skills and sales tools and software. · Extensive business travel (>50%) required COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: · Experience with specialty pharmaceutical products - reimbursement and contracting · Established relationships with key IDN customers (Providence, University of Washington, and Multicare) · Demonstrated ability to develop credible relationships at high levels within accounts · Demonstrated ability to work in collaboration with internal and external stakeholders · Ability to learn and apply scientific and clinical data with key accounts · Possesses strong business acumen negotiation and presentation skills · Exemplary interpersonal communication skills, both oral and written · Demonstrated effectiveness working independently and in groups in a collegial manner, including cross functional teams and internal/external networking · Highly results focused · Flexibility and agility, while maintaining a strong positive attitude · Ability and willingness to meet critical deadlines · Self-motivated with a strong goal and results orientation · Superior organizational, analytical and time management skills · Proactive decision making and problem-solving skills to resolve customer issues quickly and creatively · Excellent business judgment with the ability to make short and long-term business decisions while recognizing important trends BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts SALARY RANGE: $140,000.00 - $175,000.00 USD Annual GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $140k-175k yearly Auto-Apply 16d ago
  • VP, Federal Government Affairs

    Indivior 4.8company rating

    Remote Indivior job

    TITLE: VP, Federal Government Affairs Title: VP, Federal Government Affairs Reports To: EVP, Corporate Affairs Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: The Vice President, Federal Government Affairs is responsible for developing and implementing a proactive public policy strategy to promote and protect business interests with a key focus on addiction policy, and on ensuring patient access to addiction treatment generally, among other goals. This individual will design and implement integrated government affairs strategies that combine federal engagement with strategic third-party advocate development, oversee the engagement at all levels of the Federal government and is responsible for broadening Indivior's presence in Washington. This executive will identify and anticipate emerging policy and administration developments, maintain effective communication with senior leadership, and adjust the government affairs strategy as needed. The role will report to the EVP, Corporate Affairs, as it is essential for government affairs initiatives to be aligned with the broader Corporate Affairs strategy. Further, this role will work collaboratively with the company's business teams, having aligned priorities with commercial, legal, and compliance to help develop and advocate for the company's positions on federal public policy matters. The role requires a seasoned professional with a deep understanding of the Federal landscape and a proven track record in corporate government relations. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: · Works collaboratively with commercial, market access, medical affairs, corporate affairs, legal, and compliance to ensure alignment, and establish fully integrated and strategic federal government affairs and alliance development plans to advance company objectives · Build and maintain relationships with members of Congress, executive branch officials, federal agencies and trade associations, and mobilize around shared interests. · Build and strengthen relationships with patient groups, professional associations, think tanks, and other external organizations to ensure broad support for evidence-based policy solutions and to reinforce Indivior's reputation as a partner in addressing national health priorities. · Serve as a thought partner to senior leadership on issues related to federal government affairs. Assess public policy environment, determine where legislative and regulatory action is advisable and where it is not, and make recommendations on Indivior action · Manages coordination and interfaces with key legislative consultants, advocacy groups, think tanks, foundations, and associations · Develop a proactive and reactive policy agenda to create new frameworks that support Indivior's product portfolio · Enhance Indivior's visibility and reputation in federal government through partnership with the business and the broader Corporate Affairs team. Support positioning the organization as a thought leader in health care policy · Demonstrate positive leadership for the Federal Government Affairs team, effectively managing people, operations, budgets, and resources MINIMUM QUALIFICATIONS: · BS or BA degree required · 15+ years of experience in Pharmaceuticals, Government, Government Affairs, or Policy. Strong preference for experience on Capitol Hill, federal agency or similar · Extensive knowledge of the U.S. health care system · Previous work history within the pharmaceutical and/or biotechnology industry a must · Experience managing and developing teams · Effectively manage multiple projects or roles in a rapidly evolving environment · Exhibit acute political sensitivity · Ability to work cross-functionally in an organization and partner with outside groups such as advocates and associations COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: · Hands-on, with a demonstrated ability to see around corner and anticipate both opportunities and challenges in the current U.S. healthcare environment, including Medicare/Medicaid programs · Exhibits a proactive mindset · Operate as an enterprise-wide leader · Working knowledge of general U.S. government affairs compliance, including lobbying disclosure and LD- 203 requirements and supportive processes · Strong executive presence, communication, and influencing skills · Skilled writer and communicator who can vary levels of messaging based on audience · Results-oriented, self-starter with demonstrated ability to distil complex issues into concise talking points, position papers, and slides; attention to detail; ability to multi-task; team player, with an ability to work independently in a fast-paced, demanding environment · Ability to travel when business critical · Excitement about the vision and mission of Indivior BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $120k-183k yearly est. Auto-Apply 25d ago
  • Specialty Pharmaceutical Sales Rep/Clinical Specialist (Northern Virginia)

    Indivior 4.8company rating

    Indivior job in Arlington, VA

    TITLE: Specialty Pharmaceutical Sales Rep/Clinical Specialist (Northern Virginia) Title: Specialty Pharmaceutical Sales Rep/Clinical Specialist Reports To: Area Sales Manager Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: The Clinical Specialist is responsible for calling on practicing physicians, hospitals, clinics and other health-related organizations within an assigned territory. The Clinical Specialist must provide the healthcare professional with the most current information pertaining to Indivior products and their approved indications in a manner which will ensure the appropriate use of these products and achieve the business potential of the territory. Accomplishments of these goals must comply with the terms and conditions outlined in the Company Policy and Procedure Manual. ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following: * Invest the time and the effort to achieve the established goals for the territory such as sales, market share, doctor calls, appropriate program planning, etc. * Monitoring and analyzing results on territory, maintaining an up to date business plan that evaluates sales effectiveness. * Ensure all required documentation, reports etc. are timely and accurate. * Demonstrate a strong clinical understanding of all aspects of Indivior products and related disease states. * Ensure clear, concise and accurate communication of product information. * Plan and organize daily sales call activities to optimize the use of time and maximize the achievement of sales objectives. * Demonstrate persistence to accomplish objectives despite disappointments and/or rejection of original efforts. * Create and maintain a positive impression with customers. * Project a professional business image as demonstrated by neat physical appearance, and appropriate manner of speech. * Maintain timely communication with Area Sales Manager and other members of the sales leadership team. * Field work with Area Sales Manager and other Indivior personnel. * Maintain all company-provided equipment in good operating condition. * Overnight attendance at sales training meetings. * Recognize changes in the work environment, to develop and implement alternate plans to achieve objectives. * Represent Indivior at national and/or local conferences if applicable. * Perform special projects and assignments as directed by the Sales Leadership team. MINIMUM QUALIFICATIONS: Education: * BS/BA degree required 1 + years of pharmaceutical/medical/healthcare or related experience Experience: * Injectable experience preferred * Specialty Pharmacy and Specialty Distributor experience preferred * Experience with selling complex specialty and buy and bill products are preferred * Previous experience selling a drug device or technology that required a change in physician protocol is preferred * Maintain valid driver's license * Strong customer focus demonstrated team work/ collaboration * Computer proficient * Working knowledge of pharmaceutical industry COMPETENCIES/CONDUCT: * In addition to the minimum qualifications, the employee will demonstrate: * Selling/ persuasive/ presentation Skills * Focused listening skills * Displays a high-level of initiative, effort and commitment to ensure the completion of assignments and projects in a timely manner * Reads situations quickly. Anticipates and adjusts for problems and roadblocks * Results driven. Steadfastly pushes self for results * Works under daily direction of the Area Sales Manager. * Works closely with other Clinical Specialists in the Area. * Cooperates with various headquarters departments, when necessary and appropriate on matters of mutual concern. * Maintain a positive working relationship with key customers and external contacts. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: * 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st * 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay * U.S. Employee Stock Purchase Plan- 15% Discount * Comprehensive Medical, Dental, Vision, Life and Disability coverage * Health, Dependent Care and Limited Purpose Flex Spending and HSA options * Adoption assistance * Tuition reimbursement * Concierge/personal assistance services * Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage * Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: * Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure * Risk IQ: Know what policies apply to your role and function and adhere to them. * Speak Up: If you see something, say something. Manager Obligations: * Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure * Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. * Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $51k-76k yearly est. Auto-Apply 20d ago
  • GMDP Auditor

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: GMDP Auditor Title: GMDP Auditor Reports To: Head of Global Quality, GxP Audit Programmes Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: The GMDP/GCP Auditor is responsible for planning, conducting and reporting audits related to Good Manufacturing and Distribution Practices (GMDP) and Good Clinical Practices (GCP) ensuring compliance with global regulatory standards and company policies. This ensures that pharmaceutical, biotechnology, and clinical pharmaceutical, adhere to applicable guidelines, maintaining product quality, patient safety, and data integrity. ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following: Audit Program Management · Develop and execute internal and external GMDP and GCP audit programs using a risk-based approach. · Ensure all audits comply with GMDP and GCP regulations and company standards. · Manage audit resources, including internal and external auditors, and maintain a qualified auditor list. · Prepare audit agendas, reports, and CAPA plans, ensuring timely documentation and follow-up. · Monitor audit status, track CAPA implementation, and ensure issue resolution. · Conduct audits of manufacturing, distribution, laboratories, investigator sites, CROs, and vendors against GMDP/GCP requirements. · · Collaborate cross-functionality with Quality, Clinical, Manufacturing, and Supply Chain teams to drive continuous improvement. Supplier Qualification and Lifecycle Management · Perform due diligence, initial qualification, requalification, and disqualification for suppliers. · Maintain and update the Commercial GMDP Approved Supplier List (ASL). · Oversee supplier transitions from R&D QA to Commercial QA during product launches. · Ensure suppliers meet regulatory and business requirements throughout their lifecycle. Vendor Agreement Management · Track vendor performance against contractual obligations and escalate issues as needed. · Support audit, inspections, and due diligences activities related to third-party vendors. CAPA and Risk Management · Develop and manage CAPA plans with auditees, ensuring timely resolution of non-conformances. · Suspend or withhold supplier qualifications for unresolved critical risks. · Conduct risk assessments and implement mitigation strategies. Regulatory Compliance and Inspection Support · Support preparation for regulatory inspections, ensuring audit documentation is accessible. · Provide guidance during regulatory authority inspections of internal and external entities. Quality Systems and Metrics · Develop and maintain quality audit systems, ensuring adherence to relevant standards. · Publish audit metrics and KPIs, including supplier risks and CAPA performance. · Report audit outcomes and risks during management reviews. Leadership and Training · Provide training on quality processes. · Lead process improvement initiatives within the GMDP and GCP QA framework. Other duties as assigned MINIMUM QUALIFICATIONS: License/Certifications: N/A Travel: Willingness to travel internationally/domestically (approximately 25-40% of time, depending on audit schedule). · Bachelor's degree from an accredited university required. · Minimum three (3) years auditing experience in a regulated environment, such as healthcare, pharmaceutical, or medical device industries. · Broad experience in pharmaceutical manufacturing and distribution. · In-depth knowledge of GCP regulations (e.g., ICH E6), FDA regulations, and other relevant guidelines governing clinical research. · Proven experience conducting GCP audits, either as an internal auditor, sponsor representative, or independent consultant. · Experience with vendor agreements and Quality Technical Agreements (QTAs). · Familiarity with virtual pharmaceutical supply chain models is advantageous. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Specific Skills and Abilities: · Strong knowledge of EU GMP, GDP, FDA, and other regulatory requirements. · Proven ability to manage audit programs, supplier qualifications, vendor agreements, and CAPAs. · Exceptional organizational, communication, and leadership skills. · Audit certification (e.g., ISO 9001, GxP) is desirable but not essential. · Strong communication skills. Key Competencies: · Problem-solving and decision-making skills. · Ability to work independently and collaboratively. · Strong focus on compliance and continuous improvement. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $41k-72k yearly est. Auto-Apply 53d ago
  • IT Compliance Lead

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: IT Compliance Lead Title: IT Compliance Lead Reports To: Director, SAP & Compliance Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: The IT Compliance Lead is a subject matter expert on computer systems validation (CSV) and is responsible for the development, maintenance and communication of global policies, procedures, best practice guidance and appropriate risk-based methodologies. This role partners with Business Units, IT teams, Quality, and Regulatory functions across multiple geographies to define computer system validation requirements and ensures IT project delivery, application management, change management and quality management solutions are managed in compliance with Pharmaceutical and Manufacturing industry regulations and department procedures. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: IT Compliance Governance: Determine strategy and roadmap for IT Compliance Mature IT Governance Keep abreast of IT Compliance trends and industry changes Team and Project Leadership: Partner with IT leadership and business functions on business initiatives Build strong and effective relationships with other IT teams to enable change initiatives. Leads and supports IT Compliance team members to improve technical abilities and career development Procedures and Controls Continue to mature IT related documentation. Review and approve IT governance and procedure documents. System Implementation and Validation Support: Provide CSV and system implementation expertise to the Business Units and IT functions. This includes consideration of, and compliance with applicable: International Pharmaceutical industry regulations and guidance INDIVIOR Global / Local policies, procedures and standards Develop and maintain global Policies, Procedures, Standards, Guidelines and Templates to support the validation of business solutions. Develop, or oversee the preparation of, key validation deliverables (validation plans, validation reports, traceability matrices etc.), gaining appropriate approvals from the Business Units, IT and Quality functions Manage the delivery (to agreed time and quality standards) from project teams of key documentation that is required to support validation (specifications, installation & testing evidence etc.), escalating where necessary to the project manager Develop, maintain, and execute training programs regarding Computer Systems Validation Provide IT Governance oversight and / or coordination for the following areas: Coordinate IT risk reviews with the IT leadership team and relevant stakeholders. Identify regulatory compliance risks and proactively work with the Business Units, IT, Quality and Regulatory to address these risks Provide compliance oversight to the IT change control process. Ensure consistency across the IT Training program. Provide administration, security and training support for systems utilized by IT compliance Monitor and continuously improve the IT and Sarbanes Oxley Act (SOX) controls. Audit related activities: Attend vendor audits as CSV and IT Compliance SME. Help to coordinate the completion of audit questionnaires by IT vendors. IT contact for internal, financial, and ITGC audits. Provide expertise and be key IT contact to the Business Units and IT in preparing for, and responding to, regulatory inspections Perform periodic reviews of computer systems to evaluate and maintain compliance status. MINIMUM QUALIFICATIONS: Education: 4-year Bachelor's Degree Field of Study: Scientific or technical discipline with focus on Information Technology or Bioscience Industry: Pharmaceuticals / Life science Computer/Application Skills: Windows, MS Office, ValGenesis, ServiceNow, Veeva Vault Quality, Adobe and DocuSign. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Experience At least 7 years' experience in pharmaceutical business processes with in-house and outsourced manufacturing and the associated IT solutions. At least 7 years' experience dealing with pharmaceutical industry regulations and guidelines (including FDA 21 CFR Part 11, EU Annex 11, GxP, GAMP) 7+ years' experience in a Computer Systems Validation role, with at least 3 years in a leadership role Experience in GxP inspections performed by regulating authorities Strong track record of contributing to projects and achieving results within a validated regulatory environment Experience working with IT validation document repository (ValGenesis), electronic signature solutions (Adobe and DocuSign), IT control management system (AuditBoard) and corporate quality management system (TrackWise and Veeva). A working knowledge of IT application development, implementation and support processes within a regulatory environment including: Project Planning Software Lifecycle (Requirements, Design, Testing, and Implementation) A working knowledge of Infrastructure Qualification Involvement in multi-functional teams as a representative of the IT function and in technical teams representing regulatory compliance requirements Experience in writing and reviewing project deliverables for validated applications Understanding of Industry Guidance, standards and techniques is essential including Attributes Customer and results orientated personality. Role requires effective communication and team skills. Support, diagnostic and problem-solving skills experience. Flexibility in thinking/action and pragmatic in solving problems. Flexibility in role and approach, comfortable with adopting and adapting different roles as required. Fluency in English is essential. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $93k-124k yearly est. Auto-Apply 60d+ ago
  • IT Supply Applications Lead

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: IT Supply Applications Lead Title: IT Supply Applications Lead Reports To: Director SAP & Compliance Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: A business focused IT Supply Applications Lead that can leverage their strong functional hands-on applications and reporting experience in supporting SAP and other key applications relevant to the Supply function which covers Supply Chain & Distribution, Manufacturing and Quality. This will be an opportunity to work closely with key Supply business and IT stakeholders to define and deliver continuous improvement roadmap opportunities for Indivior. The IT Supply Applications Lead will act as a liaison, change enabler, and project manager between Business, IT functions and external partners to maintain and build solutions that help Indivior operate more effectively and efficiently. The role relies heavily on internal consulting skills, Supply, Manufacturing and Quality Operations business knowledge and relevant SAP and associated Manufacturing and Supply solution expertise to improve business processes and reporting within a pharmaceutical environment. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: Supply Application Strategy: Determine strategy and roadmap for Supply business functions Keep abreast of manufacturing, regulatory, industry and technology changes Stakeholder Management / Partnership & Governance: Work with the Supply business to identify business and IT roadmap opportunities, and with the wider business to increase the efficiency and utilization of systems. Mature IT / Supply Governance & lead regular business reviews Ensure all super users are trained and have access to support and materials to fulfil their roles. Work with super user groups to implement best practices across the population. Application Management: Responsible for aspects of license and vendor management for support partners and software vendors Partner with internal and external vendors on development and support, ensuring any support issues are escalated and prioritized appropriately. Work closely with the business and Information Security to identify and mitigate security risks. Support internal and external audits to ensure systems are compliant with all relevant policies. Define and evolve application management approach for the systems including system specific change management and application administration Team and Project Leadership: Build strong collaborative relationships with key business partners and IT colleagues that enables effective support and solution implementation. Strong leadership and management skills to facilitate offshore and onsite vendor and internal support teams, working across geographies to ensure company SLA's are met. Support and coach team members, and guide external vendors, to meet business objectives. Manage IT and business facing projects by leading teams to meet schedule, budget, and quality. Manage key risks, issues, actions, and decisions in timely manner. Identify workload and resourcing constraints and propose options to prioritize and deliver solutions Procedures and Controls: Continue to mature IT and business processes and associated training documentation. Review and approve IT procedures and controls. Application Support and Administration: Be responsible for the teams who manage day to day incidents and requests for several business systems, ensuring these are managed in line with SLA's, and Indivior IT best practices. Maintain the system operation as required by the business and in line with Indivior Policies and SOP's. Complete regular IT administration activities, covering: Ongoing training and support for super users/users Oversee interfaces and critical jobs Execution and review of scheduled Sarbanes Oxley Act (SOX) and IT General controls Projects and Enhancements: Act as Project Manager for system improvement projects and enhancements, and input into other projects that may impact upon the applications being managed. Hands on capability in all aspects of the project lifecycle, including gathering requirements, Gap Analysis and blueprinting, system configuration, customization, testing, documenting, deployment and training end-users on SAP and associated applications Collecting business requirements and completing assessments for enhancement requests across Supply functions for SAP and associated applications Design and implement solutions and continual business process improvements for Supply applications Design and author training & knowledge articles, standard operating procedure documents, functional and technical design documents, ensuring that documentation specific to Indivior's Good Documentation Practices as per the standards set by Quality and Compliance department Lead the development of testing requirements, script preparation and successful testing completion as per defined testing standards Define cutover and deployment plans and lead the rollout of changes and projects to business teams ensuring communication, training and support issues are completed timely to enable successful implementation MINIMUM QUALIFICATIONS: Education: 4-year Bachelor's Degree Field of Study: Business / Engineering or Supply / Operations discipline with focus on Information Technology Industry: Pharmaceuticals / Life science / Manufacturing Computer/Application Skills: Windows, MS Office, ValGenesis, ServiceNow, SAP MM, SAP SD, SAP PP-PI, SAP WMS, SAP IBP, SAP BI, Power BI, Veeva QMS, Manufacturing Execution Systems. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Experience At least 7 years' experience in IT Management of Supply function applications and business processes with in-house and outsourced manufacturing within a Pharmaceutical / Regulated environment. Minimum 10 years SAP MM, SD, PP, WMS experience with significant integration knowledge across adjacent SAP FICO modules and reporting Demonstrated experience operating within an SAP “Global Template” environment with multi-national manufacturing / sub-contracting companies and intercompany processes Process reengineering experience optimizing Global Supply with Internal and external Manufacturing models Demonstrated Implementation & support experience of integrating SAP with external partners Knowledge and experience with SAP SCM applications (APO-DP/SNP, Flexible Planning) and SAP IBP Demand/Supply desired Knowledge and experience with Manufacturing Execution, Quality and Serialization systems (TraceLink) well regarded Strong track record of contributing to projects and achieving results within a validated regulatory environment Attributes Customer and results orientated personality. Role requires effective communication and team skills. Support, diagnostic and problem-solving skills experience. Flexibility in thinking/action and pragmatic in solving problems. Flexibility in role and approach, comfortable with adopting and adapting different roles as required. Fluency in English is essential. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $90k-117k yearly est. Auto-Apply 14d ago
  • Sr. Financial Analyst

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: Sr. Financial Analyst Title: Senior Financial Analyst, FP&A Reports To: Commercial Controller Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: The Senior Financial Analyst, FP&A will serve as a strategic partner in driving financial performance and supporting key business decisions across the organization. This role is responsible for delivering advanced financial analysis, forecasting, and reporting, with a strong emphasis on cross-functional collaboration, financial rigor, and strategic insight-particularly within a pharmaceutical environment. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: Analyze monthly and quarterly financial results, identify key trends and variances, and provide strategic recommendations to leadership. Lead the development and enhancement of financial models to support budgeting, forecasting, and long-range strategic planning. Translate complex financial data into clear, compelling narratives to communicate findings and recommendations to stakeholders. Review, validate and consolidate forecasts for U.S. and international markets, ensuring accuracy, consistency, and alignment with planning and reporting requirements. Act as a financial systems expert (SAP, BI tools), driving optimization and providing guidance to cross-functional teams. Perform and lead ad-hoc analyses to evaluate business performance, investment opportunities, and support strategic initiatives. Ensure adherence to internal controls, financial policies, and compliance standards, while identifying opportunities for process improvement. MINIMUM QUALIFICATIONS: 3-5 years of relevant professional experience in financial analysis, accounting, or a related field. Bachelor's degree in finance, Accounting, Economics, or a related field. MBA or CPA preferred. Experience with foreign exchange rate analysis preferred. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Strong analytical and problem-solving skills. Advanced Microsoft Excel skill with proficiency in Microsoft Office Good knowledge of ERP, preferably SAP. High attention to detail and accuracy. Ability to work independently and collaboratively. Excellent interpersonal and communication skills. Demonstrated integrity and ethical standards. Curiosity and eagerness to learn. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $70k-95k yearly est. Auto-Apply 17d ago
  • Indirect Procurement Manager- RD, Medical Affairs, Supply and IT

    Indivior 4.8company rating

    Indivior job in Richmond, VA or remote

    TITLE: Indirect Procurement Manager- RD, Medical Affairs, Supply and IT Title: Indirect Procurement Manager Reports To: Head of Procurement Hybrid Working Solution: as a minimum office attendance Tuesday - Thursday, with remote working option on Monday and Friday Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: As a member of the Global Procurement Team, the Indirect Procurement Manager will be a valued business partner to various Indivior Business Functions potentially including R&D, Commercial, HR and Manufacturing & Supply. This role partners closely with the related functional stakeholders to ensure supplier solutions align with their strategies, compliance requirements, and business objectives. The ideal candidate brings deep category expertise, strong stakeholder engagement, and a strategic mindset to drive value, innovation, and risk mitigation across the supplier base. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: · Lead category strategy development, optimization and execution to support various functions including R&D, Medical Affairs, IT and Supply (incl. MRO, CAPEX…). · Develop sourcing plans collaboratively with Stakeholders to deliver best results in minimizing risk and costs, and delivering additional value levers and innovation to the organization. · Partner with internal stakeholders to understand business needs, and translate them into sourcing strategies. · Manage end-to-end sourcing processes including RFPs/RFQs/RFSs, supplier selection, contract negotiation, and performance management. · Ensure compliance with internal policies, regulatory requirements and risk management frameworks. · Monitor supplier performance and lead continuous improvement initiatives to enhance service delivery and cost efficiency. · Design, implement and maintain accurate and reliable spend and savings reporting with respect to projects and suppliers. · Maintain up-to-date knowledge, market trends, supplier innovations, and emerging technologies relevant to assigned categories MINIMUM QUALIFICATIONS: · Bachelor's degree in Business, Supply Chain, Life Sciences, Engineering or related field; advanced degree or certifications (e.g., CPSM, CIPS) preferred. · 5+ years of indirect procurement or category management experience. · Proven ability to manage complex sourcing initiatives across multiple functional areas and negotiate high-value contracts. · Excellent communication, stakeholder management, and negotiation skills. · Proficiency in procurement tools (e.g., SAP, Ariba, Coupa) and Microsoft Office Suite. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: · Strong commercial acumen and negotiation skills. · Strategic thinking. · Excellent collaboration and relationship-building skills at all levels including executives. · High ethical standards and compliance orientation. · Adaptability and ability to manage ambiguity, and drive results in a dynamic environment. · Continuous improvement mindset and openness to innovation. · Clear and persuasive communication skills. · Ability and flexibility BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: · 3 weeks' vacation plus floating holidays and sick leave · 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay · U.S. Employee Stock Purchase Plan- 15% Discount · Comprehensive Medical, Dental, Vision, Life and Disability coverage · Health, Dependent Care and Limited Purpose Flex Spending and HSA options · Adoption assistance · Tuition reimbursement · Concierge/personal assistance services · Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage · Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: · Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure · Risk IQ: Know what policies apply to your role and function and adhere to them. · Speak Up: If you see something, say something. Manager Obligations: · Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure · Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. · Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $76k-105k yearly est. Auto-Apply 44d ago
  • Sr. Manager, Quality Validation

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: Sr. Manager, Quality Validation Title: Sr. Manager, Quality Validation Reports To: Head, Quality Operations, North America Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: The Sr. Manager, Quality Validation is responsible for developing validation strategy for Indivior and third-party manufacturing, packaging and testing. This role ensures compliance with regulatory requirements, industry standards, and develops company policies for validation of equipment, utilities, processes, computer systems, cleaning, and facilities. The Sr. Manager, Quality Validation will serve as the validation subject matter expert (SME) within Indivior. The Sr. Manager, Quality Validation interacts with the local site validation teams to provide the strategy as well as execution, as needed. This position is critical for maintaining product quality, patient safety and compliance with regulatory standards within the US and Most of World. ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following: Develop, implement and maintain the Indivior validation policy and validation master plan Lead validation activities for process validation, sterile manufacturing, oral solid dose, utilities, and computer systems Oversee validation activities at third party CMO/CPO to ensure compliance with internal and regulatory requirements Author, execute, review and approve validation protocols, summary report and supporting documentation Ensure validation activities meet Annex 1, FDA, EMA and ICH requirements Maintain validation systems in compliance with cGMPs and global regulations Support regulatory inspections, audits, and due diligence reviews as the SME for validation Partner with CMOs to ensure validation programs are robust and compliant Collaborate cross functionally with Quality, Manufacturing, Regulatory and IT teams to align validation strategies with Indivior goals Implement risk-based validation approach as applicable to improve efficiency Identify and drive opportunities for system and process improvements Ensures that validation documentation provided by third party suppliers complies with all required Indivior and Regulatory standards Lead or support the development of User Requirement Specifications (URSs) Lead or support factory acceptance tests and site acceptance tests, review protocol, approve protocol, participate in FAT/SAT execution, review and approval FAT/SAT final report Lead or support risk assessments associated with validation equipment and process validation activities Support engineering studies led by the Technical Operations/Engineering Teams/CMC internally and externally w/CMOs/CPOs Support any regulatory requests pertaining to updates to the regulatory dossier associated with validation Ensure annual validation and requalification activities are performed internally and externally Lead or support Installation Qualification/Operational Qualification/Performance Qualification and Process Validation (PV) activities Maintain the Indivior Validation Policy, internal validation master plans (VMPs), validation standard operating procedures (SOPs), work instructions (WI) Must have strong technical understanding of GxP pharmaceutical equipment, facilities and processes Must have strong root cause analysis skills for authoring deviations and identifying the necessary CAPAs Must have strong leadership and communication and able to facilitate investigations across multiple functions and complete within the required timelines Drives completion of deviations and ensures CAPA have been implemented and monitored for effectiveness to ensure Indivior has a quality centric continuously improving business Participates in and provide quality input to project teams supporting new product launches Participates in New and Existing Product development through the technical transfer and validation process Participates in Continuous Improvement activities including procedural enhancements to support the commercial activities in North America In conjunction with Global Quality Management and the OPEX team, develops and carries out training programs to ensure relevant Indivior policies/procedures and local QMS requirements are relayed to appropriate staff Any other duties as determined by management to support North America Quality team. Some US and International travel required (approximately 10%) to support vendor relations, audit program and work with the global quality team MINIMUM QUALIFICATIONS: Bachelor's degree in Engineering, Life Sciences or related field in a relevant scientific discipline from an accredited university required (Master's degree preferred) Minimum ten (10) years of pharmaceutical manufacturing or quality with at least eight (8) years in validation, executing and leading validation teams in a regulated industry such as FDA, pharmaceutical or medical device Direct experience in root cause analysis (RCA) and critical thinking Strong sterile and microbiological experience Strong understanding of small molecule products Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S, ISO, etc. Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action Strong Leadership, communication and listening skills Excellent communication skills - presentation, written and oral Proven ability to work under pressure without compromising deliverables Collects, understands, interprets, and trends data on quality system performance Strong computer and technical skills including Microsoft platform, SAP, Kaye, VEEVA, AI, validation equipment i.e. Kaye Validator, Val Probes, ellabs, thermocouples, building management (BMS) systems, equipment HMI, filling equipment, autoclaves, HVACs, CTUs, portable monitoring devices, etc. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Follow Indivior Guiding Principles Proficiency in Risk Assessment skills to support deviation investigations, change management and CAPA. TRAVEL: Less than 10% travel. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $64k-87k yearly est. Auto-Apply 56d ago
  • Manager of Accounting, Manufacturing and Operations

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: Manager of Accounting, Manufacturing and Operations Title: Manager of Accounting, Manufacturing and Operations Reports To: Head, Global Finance Operations Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: Indivior is looking for a Manager of Accounting (Manufacturing and Operations) at its Richmond, VA headquarters. This position supports inventory accounting with internal factories and third-party contract manufacturing organizations (CMO) as well as support the general accounting for operating expenses/business functions. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: · Provide strategic financial leadership, coaching, and direction to Supply team members to achieve optimal business results and best practices regarding supply accounting (including monthly reconciliations of SAP to CMO reports). · Coordinate all supply chain period-end closing activities with support from the business and global supply operations resources to ensure timely completion of assigned tasks, including identification and resolution of unusual items and issues in a timely and accurate manner. · Preparation of all period-end closing entries related to 1) Supply Chain inventories (raw materials, semi-finished goods and finished goods) 2) Inventory reserves and 3) COGS. · Coordinate and ensure that inventory reserves are accounted for cross-company for future finished goods intercompany sales based on current supply and operations production forecasts in line with regional sales forecasts. · Prepare monthly balance sheet reconciliations and internal control documentation related to all supply chain inventory accounts to ensure timely performance of reconciliations and adequate supporting documentation within the Blackline and SOXHUB systems. · Interface with Global accounting partners to ensure proper and timely processing of intercompany transactions related to intercompany inventory movements. · Annually, prepare inventory standards and ensure proper reflection of the revaluation of standards and subsequent impacts to the P&L. · Review of annual standard calculations to ensure proper costing for cost to group, profit in stock, transfer prices and intercompany selling prices. · Maintain full ownership of the calculation and set-up of purchasing information records, transfer prices and intercompany sales prices within SAP. · Provide monthly COGS actuals, tracking and bridge analyses. Additionally, support budgeting process for COGS. · Serve as liaison for all internal and external supply chain accounting inquiries and processes subject to audit. · Coordinate with external and internal auditors to ensure timely completion of audit requests, and aid in the research and analysis of audit issues raised. · Improve core controllership processes for global supply chain accounting by identifying gaps in Supply Chain accounting processes and establishing process improvements across all product lines within Supply chain in conjunction with internal global supply operations resources and the external CMO teams. · Partner with internal supply chain management team, site operations teams, Global accounting teams and FP&A in order to support business initiatives by understanding context, providing ideas and insights, partnering on creating processes that scale, and providing accounting guidance as needed. · Review and document approvals of general accounting entries related to operating expenses. · Support tax inquiries and reporting as needed quarterly and annually. MINIMUM QUALIFICATIONS: · Bachelor's degree in accounting or finance required · 10+ years accounting experience · Below 10% domestic travel · SAP experience preferred COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: · Ability to interact successfully within finance and cross-functionally, including influencing business leaders · Strong oral and written communication skills · Ability to multi-task and re-prioritize as necessary · Analytical and detail-oriented · Able to perform within tight deadlines in a fast-paced environment · Strong desire for continuous improvement; willingness to challenge status quo · Proficiency with Microsoft 365 (Excel especially) BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $72k-100k yearly est. Auto-Apply 22d ago
  • IT Senior Application Analyst - HRIS

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: IT Senior Application Analyst - HRIS Title: IT Senior Application Analyst - HRIS Reports To: Senior Business Applications Manager Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: The IT Senior Application Analyst is a subject matter expert covering Human Resources business functions and is responsible for supporting the design, build and run phases for applications. This role partners with HR and Business teams and within IT to assess, prioritize and support continuous improvement initiatives. The role holder will oversee the day-to-day service delivery (including incident management) for Workday, and manage the application support vendor, ensuring critical issues are escalated appropriately and operations are in line with Indivior SOP's and policies. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: Contribute to IT and Business Applications roadmap Participate as key resource in system enhancements and projects Deliver effective business support and facilitate with vendors for issues and enhancements. Build and maintain strong relationships with internal and external stakeholders, to manage expectations on performance, requirements, and delivery Application Support and Administration: Oversight of the team managing the incidents and requests for Workday Support the system operation as required by the business and in line with Indivior Policies and SOP's. Complete regular IT administration activities, covering HR support, including updating materials for new business processes Support the Payroll processes across Workday and ADP solutions Execution of IT and Sarbanes Oxley controls Review of incident metrics with line manager and support teams Build out and maintain the Workday intranet page, ensuring this has engaging and intuitive content. Support release management processes for Workday and associated applications Application Management: Provide Subject Matter IT application knowledge for design, build and run for HR Applications Act as primary contact point for the outsourced vendor team to deliver services within service level agreements for IT, and in line with Indivior policies and SOP's Work with business and IT teams to enable effective delivery of key initiatives Procedures and Controls Continue to mature IT related documentation. Review and approve IT governance and procedure documents. Stakeholder Management/Partnership: Meet regularly with HR to take feedback and use this information to input into improvement opportunities for systems and processes Empower HR and business users towards greater self-service and ensure best practices are implemented across the systems and processes Support HR team members and business users on Workday functionality and usage Projects and Enhancements: Work closely with HR, Payroll, the IT management and other key stakeholders to build a HR Applications roadmap Work with IT management, HR and vendors to help prioritize and plan changes, ensuring requirements are clearly translated into any technical/functional changes Lead and support changes and enhancements throughout the design/build (system and process documentation) and testing phases (change documentation) Team and Project Leadership: Build strong collaborative relationships with key business partners and IT colleagues that enables effective support and solution implementation Good team leadership skills to facilitate outsourced vendor and internal support teams, working across geographies to ensure company SLAs are met Support IT and business facing projects and teams to meet schedule, budget, and quality. Address key risks, issues, actions, and decisions in timely manner Work with IT operational and technical support to provide a high-quality user experience MINIMUM QUALIFICATIONS: Education: 4-year Bachelor's Degree Field of Study: Human Resources, Business or Information Technology Industry: Pharmaceuticals / Life science Computer/Application Skills: Windows, MS Office, Workday, ServiceNow, SuccessFactors. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Experience Minimum 5 years application management across business processes and/or IT, experience of working closely with HR teams and processes is essential. Experience, or a strong understanding, of key Workday modules such as Core HCM, Recruiting, Advanced Compensation, Talent, and Absence Management is desired. Minimum 3 years experience of coordinating outsourced application support providers. Demonstrated experience in governance, business process improvement, system design, documentation and testing in a regulated continuous improvement environment. Demonstrated experience of supporting end users, and super users, including 1-2-1 support and development of training materials. Attributes Customer and results orientated personality. Role requires effective communication and team skills. Support, diagnostic and problem-solving skills experience. Flexibility in thinking/action and pragmatic in solving problems. Flexibility in role and approach, comfortable with adopting and adapting different roles as required. Fluency in English is essential. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $85k-109k yearly est. Auto-Apply 60d+ ago
  • Director, IT - Commercial Applications, Business Intelligence

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: Director, IT - Commercial Applications, Business Intelligence Title: Director, IT - Commercial Applications, Business Intelligence Reports To: CIO Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: We are seeking a visionary and results-driven Director of IT to lead the strategy, development, and optimization of Commercial Applications, Business Intelligence (BI), and Artificial Intelligence (AI). This role will be instrumental in driving digital transformation, enhancing commercial effectiveness, and enabling data-driven decision-making across Sales, Marketing, Market Access, and Patient Services. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: Strategic Leadership Define and execute the IT roadmap for Commercial Applications, BI, and AI aligned with corporate and commercial business strategies. Partner with Commercial, Data Science, and Analytics leaders to identify opportunities for innovation and operational efficiency. Lead cross-functional teams to deliver scalable, secure, and compliant technology solutions. Commercial Applications Oversee the implementation and lifecycle management of Veeva CRM and other commercial platforms. Ensure seamless integration of commercial systems with ERP, data lakes, and third-party data providers. Drive enhancements to support field force effectiveness, omnichannel engagement, and HCP/patient insights. Business Intelligence & Data Analytics Lead the BI strategy, including data architecture, visualization tools (e.g., Tableau, Power BI), and self-service analytics. Establish KPIs and dashboards to monitor commercial performance, market trends, and customer engagement. Ensure data governance, quality, and compliance with industry regulations (e.g., HIPAA, GDPR). Artificial Intelligence & Advanced Analytics Champion the adoption of AI/ML models to optimize targeting, forecasting, segmentation, and personalization. Collaborate with data science teams to operationalize predictive and prescriptive analytics. Evaluate emerging technologies and vendors to accelerate AI maturity across the organization. MINIMUM QUALIFICATIONS: Bachelor's degree in Computer Science, Information Systems, or related field; Master's or MBA preferred. 10+ years of progressive IT leadership experience, with at least 5 years in the pharmaceutical or life sciences industry. Proven track record in managing commercial applications, BI platforms, and AI initiatives. Deep understanding of commercial pharma operations, data ecosystems, and regulatory requirements. Strong vendor management, project delivery, and stakeholder engagement skills. Experience with cloud platforms (AWS, Azure), data lakes, and modern data stack tools. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Familiarity with Veeva CRM, IQVIA data, and AI/ML frameworks. Change management and agile delivery experience. Excellent communication and leadership skills with the ability to influence at all levels. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $113k-163k yearly est. Auto-Apply 23d ago
  • Area Sales Director (Great Lakes)

    Indivior 4.8company rating

    Remote Indivior job

    TITLE: Area Sales Director (Great Lakes) Title: Area Sales Director Reports To: Commercial Head Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: Develops implements and subsequently monitors strategic plans for the Area to deliver Area results per Indivior specifications. Critical responsibilities include the timely recruitment, selection, and evaluation of the highest quality Clinical Specialists and Institutional Specialists. Trains, coaches, and develops team in best practice methods to achieve goals and objectives. The Area Sales Director regularly provides sales direction and guidance to the Clinical Specialists and Institutional Specialists. The Area Sales Director is responsible for operations of the Area, including meeting revenue goals for the Area and expense management. Recognizes and responds to changing needs. Regularly communicates with field representatives, supervisors, home office staff, and pre-authorized client personnel. Accomplishment of these goals must comply with all Indivior policies and procedures. ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following: • Deliver Indivior goals/results for assigned area such as sales, market share, targeted calls. • Responsible for expense management/profitability, monitoring ROI. • Participate in and contribute to accomplishments of the business objectives. • Develop and implement business plans, develop and maintain new and innovative ideas, strategies, marketing plans of action and budgetary control ensuring compliance with all Indivior policies and procedures. • Plan, organize and monitor Clinical Specialist's and Institutional Specialist's assignments, activities and projects to achieve Indivior objectives, providing on-going and regular feedback. • Effectively plan and conduct required meetings with members of the assigned area. • Working with National Sales Directors and human resources, identify and implement initiatives to reduce turnover and vacancies. • Implement and monitor all field-based training. • Conduct field visits with each Clinical Specialist and Institutional Specialist on a routine basis. Utilize coaching and counseling to improve their selling skills, product knowledge and overall effectiveness in accordance with Indivior standards. • Develop sales team in assigned area. Provide counseling and career development planning. • Maintain the required technical expertise including competitive product knowledge. • Respond appropriately to changing conditions and individuals within the assigned area in order to encourage and enhance professional working relationships. • Ensure that field sales personnel store all company-supplied equipment/records, and promotional material according to prescribed conditions and legal requirements. • Ensure adherence to all Fleet policies and programs for self and team • Overnight Travel as required. • ** Perform special projects as assigned. MINIMUM QUALIFICATIONS: Education: • BS/BA degree required; an advanced degree a plus in addition to 5 + years of pharmaceutical/medical/healthcare or related experience Experience: • 3+ years in a people manager role desired • Relative experience in related disease space • Injectable experience preferred • Specialty Pharmacy and Specialty Distributor experience preferred • Experience with selling complex specialty and buy and bill products are preferred • Previous experience selling a drug device or technology that required a change in physician protocol is preferred • Maintain valid driver's license • Computer proficient Computer Skills: • Proficiency in Excel, Word, Outlook, and PowerPoint License/Certifications: • Valid driver's license with a safe driving record that meets company requirements Other Requirements: • Must be able to sit for long periods of time • Lift 35lbs as necessary • Travel long distances either in car or other modes Travel: • Domestic and international travel as required; overnights as required > 50% COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: • Ability to recruit, retain and develop highest quality staff; ability to manage turnover and vacancy process • Ability to maximize assigned area profitability and ensure compliance • Record of positive relationship management skill BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $60k-100k yearly est. Auto-Apply 23d ago
  • GMDP Auditor

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: GMDP Auditor Title: GMDP Auditor Reports To: Head of Global Quality, GxP Audit Programmes Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: The GMDP/GCP Auditor is responsible for planning, conducting and reporting audits related to Good Manufacturing and Distribution Practices (GMDP) and Good Clinical Practices (GCP) ensuring compliance with global regulatory standards and company policies. This ensures that pharmaceutical, biotechnology, and clinical pharmaceutical, adhere to applicable guidelines, maintaining product quality, patient safety, and data integrity. ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following: Audit Program Management * Develop and execute internal and external GMDP and GCP audit programs using a risk-based approach. * Ensure all audits comply with GMDP and GCP regulations and company standards. * Manage audit resources, including internal and external auditors, and maintain a qualified auditor list. * Prepare audit agendas, reports, and CAPA plans, ensuring timely documentation and follow-up. * Monitor audit status, track CAPA implementation, and ensure issue resolution. * Conduct audits of manufacturing, distribution, laboratories, investigator sites, CROs, and vendors against GMDP/GCP requirements. * · Collaborate cross-functionality with Quality, Clinical, Manufacturing, and Supply Chain teams to drive continuous improvement. Supplier Qualification and Lifecycle Management * Perform due diligence, initial qualification, requalification, and disqualification for suppliers. * Maintain and update the Commercial GMDP Approved Supplier List (ASL). * Oversee supplier transitions from R&D QA to Commercial QA during product launches. * Ensure suppliers meet regulatory and business requirements throughout their lifecycle. Vendor Agreement Management * Track vendor performance against contractual obligations and escalate issues as needed. * Support audit, inspections, and due diligences activities related to third-party vendors. CAPA and Risk Management * Develop and manage CAPA plans with auditees, ensuring timely resolution of non-conformances. * Suspend or withhold supplier qualifications for unresolved critical risks. * Conduct risk assessments and implement mitigation strategies. Regulatory Compliance and Inspection Support * Support preparation for regulatory inspections, ensuring audit documentation is accessible. * Provide guidance during regulatory authority inspections of internal and external entities. Quality Systems and Metrics * Develop and maintain quality audit systems, ensuring adherence to relevant standards. * Publish audit metrics and KPIs, including supplier risks and CAPA performance. * Report audit outcomes and risks during management reviews. Leadership and Training * Provide training on quality processes. * Lead process improvement initiatives within the GMDP and GCP QA framework. Other duties as assigned MINIMUM QUALIFICATIONS: License/Certifications: N/A Travel: Willingness to travel internationally/domestically (approximately 25-40% of time, depending on audit schedule). * Bachelor's degree from an accredited university required. * Minimum three (3) years auditing experience in a regulated environment, such as healthcare, pharmaceutical, or medical device industries. * Broad experience in pharmaceutical manufacturing and distribution. * In-depth knowledge of GCP regulations (e.g., ICH E6), FDA regulations, and other relevant guidelines governing clinical research. * Proven experience conducting GCP audits, either as an internal auditor, sponsor representative, or independent consultant. * Experience with vendor agreements and Quality Technical Agreements (QTAs). * Familiarity with virtual pharmaceutical supply chain models is advantageous. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Specific Skills and Abilities: * Strong knowledge of EU GMP, GDP, FDA, and other regulatory requirements. * Proven ability to manage audit programs, supplier qualifications, vendor agreements, and CAPAs. * Exceptional organizational, communication, and leadership skills. * Audit certification (e.g., ISO 9001, GxP) is desirable but not essential. * Strong communication skills. Key Competencies: * Problem-solving and decision-making skills. * Ability to work independently and collaboratively. * Strong focus on compliance and continuous improvement. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: * 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st * 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay * U.S. Employee Stock Purchase Plan- 15% Discount * Comprehensive Medical, Dental, Vision, Life and Disability coverage * Health, Dependent Care and Limited Purpose Flex Spending and HSA options * Adoption assistance * Tuition reimbursement * Concierge/personal assistance services * Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage * Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: * Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure * Risk IQ: Know what policies apply to your role and function and adhere to them. * Speak Up: If you see something, say something. Manager Obligations: * Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure * Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. * Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $41k-72k yearly est. Auto-Apply 60d+ ago
  • Marketing Product Manager - SUBLOCADE

    Indivior 4.8company rating

    Remote Indivior job

    TITLE: Marketing Product Manager - SUBLOCADE Title: Product Manager - SUBLOCADE Reports To: SVP Marketing Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: This role serves as both the process owner for all Promotional Review Committee (PRC) planning, operations, and communications, as well as lead for key marketing projects across channels in the US (e.g., HCP, DTP, B2B). The incumbent will ensure compliant, efficient, and effective administration of PRC submissions and committee processes, while also developing and executing marketing tactics and strategies for promoted products. The position requires strong cross-functional collaboration, stakeholder engagement, and project management skills to drive both regulatory adherence and commercial success. The ideal candidate will have strong marketing & communication abilities, and a deep understanding of the promotional review process in the pharmaceutical industry. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: Marketing Project Ownership Develop and execute cross-channel marketing tactics and campaigns to promote pharmaceutical products, including project development, content creation and ownership through MLR reviews. Collaborate with sales, medical affairs, regulatory, and external vendors to align marketing strategies and drive product adoption. Manage marketing budgets and vendor relationships to support initiatives. Ensure all marketing activities comply with industry regulations and company policies. Prepare and present regular reports on marketing activities and tactical performance. PRC Management Lead PRC submission and committee process, including prioritization of submissions based on capacity and business need. Partner effectively with Operations, Brand, Training, Medical, Legal and Regulatory team leads. Facilitate pre-meeting reviews, meetings, document outcomes, and ensure consistent application of PRC standards. Escalate significant issues to the PRC Steering Committee as needed. Ensure MLR comments are incorporated into updated versions of materials and monitor status when materials are “Approved for Use.” Continuously improve PRC workflows, tools, and policies to streamline processes, systems and maintain compliance. Monitor and report on key PRC and marketing metrics, dashboards, and compliance indicators. MINIMUM QUALIFICATIONS: Bachelor's degree in Life Sciences, Marketing, Business Administration, Healthcare Administration, or related field; advanced degree preferred. Minimum of 5 years of experience in the pharmaceutical or biotech industry, with a focus on promotional review, regulatory affairs, marketing operations, and/or product management. Strong knowledge of regulatory requirements (e.g., FDA) and industry standards for pharmaceutical promotional materials review and approval. Demonstrated expertise in process management, cross-functional collaboration, and operational excellence. Experience with vendor management, policy development, and delivering training. Proficiency with compliance systems (e.g., Veeva Vault) and project management tools is a plus. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: High attention to detail and commitment to compliance. Strong marketing and product management skills; ability to manage multiple projects simultaneously. Excellent communication, organizational, and analytical skills. Ability to work independently and maintain neutrality in process oversight. Strong stakeholder management and facilitation skills. Capacity to drive process improvements and manage change in a dynamic environment. Problem-solving mindset with adaptability to changing circumstances. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $89k-126k yearly est. Auto-Apply 15d ago
  • Product Quality Lead

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: Product Quality Lead Title: Product Quality Lead Reports To: Product Quality Manager Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: This role is responsible to support the assigned areas in their ability to successfully improve operations, manufacture Indivior batches, reduce lead times and increase capacity. To ensure that all the relevant process raw materials, intermediates and final products are manufactured, packaged, tested and released in full compliance with cGMP and regulatory requirements that meet the defined quality standards for the US and Most of World. ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following: Provide direct INDV QA assistance for the resolution of deviations, escalations, and material disposition. Provide final INDV QA review of formulation, manufacturing, bulk packaging, and inspection records to ensure GMP completeness, accuracy and legibility. Provide final INDV QA review of secondary packaging records and activities Provide surge support for INDV QA Release for Supply Activities for final commercial batch disposition, as required Provide INDV QA review of artwork and component changes Provide INDV QA oversight of supplier, component and material changes impacting bulk manufacturing and secondary packaging. Provide direct support for all related continuous improvement activities as applicable. Assist in providing direction in batch disposition, along with major deviations. QA lead or support on writing and investigating minor and major deviations as required QA lead or support all on Sublocade Launches Assist in providing support in internal audit activities for GMP compliance and to identify and raise GMP issues as or if they arise. Assist Indivior Quality Validation Manager in providing support in change management and validation activities that may impact product and/or process. Assist in providing support for all changes and additions to SOP, Work Instruction, specifications and like documents. Work directly with CMO to gather and report Quality monthly metrics. Assist in providing training support for new and existing employees. Ensure that Annual Product Reviews have been completed by responsible parties and have been assessed internally against requirements and are delivered according to schedule. Author Annual Product Quality Reports Perform Mock Recall Activities Coordinate Stability Activities supporting Sublocade and ensure batches are placed on Stability Ensure that the applicable Quality Technical Agreement requirements are being met. Participate in the review, investigations and responses for product quality complaints. Any other duties as determined by management to support North America Quality team. MINIMUM QUALIFICATIONS: License/Certifications: N/A Travel: Minimum 10% Bachelor of Science degree in a relevant scientific discipline from an accredited university required. Broad Knowledge of sterile manufacturing. Proven track record, minimum five (5) years of quality experience, in a regulated industry such as FDA, pharmaceutical or medical device. Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S. Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks. Make and communicate appropriate judgments on any assessed risks to continue or suspend until risk can be mitigated. Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action. Excellent communication skills - presentation, written and oral. Proven ability to work under pressure without compromising deliverables. Collects, understands, interprets and trends data on the quality system performance. Strong computer skills including Microsoft platform and Visio. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Proficiency in conducting Risk Assessments to support deviation investigations, change management and CAPA. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $67k-93k yearly est. Auto-Apply 56d ago
  • Manager of Accounting, Manufacturing and Operations

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: Manager of Accounting, Manufacturing and Operations Title: Manager of Accounting, Manufacturing and Operations Reports To: Head, Global Finance Operations Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: Indivior is looking for a Manager of Accounting (Manufacturing and Operations) at its Richmond, VA headquarters. This position supports inventory accounting with internal factories and third-party contract manufacturing organizations (CMO) as well as support the general accounting for operating expenses/business functions. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: * Provide strategic financial leadership, coaching, and direction to Supply team members to achieve optimal business results and best practices regarding supply accounting (including monthly reconciliations of SAP to CMO reports). * Coordinate all supply chain period-end closing activities with support from the business and global supply operations resources to ensure timely completion of assigned tasks, including identification and resolution of unusual items and issues in a timely and accurate manner. * Preparation of all period-end closing entries related to 1) Supply Chain inventories (raw materials, semi-finished goods and finished goods) 2) Inventory reserves and 3) COGS. * Coordinate and ensure that inventory reserves are accounted for cross-company for future finished goods intercompany sales based on current supply and operations production forecasts in line with regional sales forecasts. * Prepare monthly balance sheet reconciliations and internal control documentation related to all supply chain inventory accounts to ensure timely performance of reconciliations and adequate supporting documentation within the Blackline and SOXHUB systems. * Interface with Global accounting partners to ensure proper and timely processing of intercompany transactions related to intercompany inventory movements. * Annually, prepare inventory standards and ensure proper reflection of the revaluation of standards and subsequent impacts to the P&L. * Review of annual standard calculations to ensure proper costing for cost to group, profit in stock, transfer prices and intercompany selling prices. * Maintain full ownership of the calculation and set-up of purchasing information records, transfer prices and intercompany sales prices within SAP. * Provide monthly COGS actuals, tracking and bridge analyses. Additionally, support budgeting process for COGS. * Serve as liaison for all internal and external supply chain accounting inquiries and processes subject to audit. * Coordinate with external and internal auditors to ensure timely completion of audit requests, and aid in the research and analysis of audit issues raised. * Improve core controllership processes for global supply chain accounting by identifying gaps in Supply Chain accounting processes and establishing process improvements across all product lines within Supply chain in conjunction with internal global supply operations resources and the external CMO teams. * Partner with internal supply chain management team, site operations teams, Global accounting teams and FP&A in order to support business initiatives by understanding context, providing ideas and insights, partnering on creating processes that scale, and providing accounting guidance as needed. * Review and document approvals of general accounting entries related to operating expenses. * Support tax inquiries and reporting as needed quarterly and annually. MINIMUM QUALIFICATIONS: * Bachelor's degree in accounting or finance required * 10+ years accounting experience * Below 10% domestic travel * SAP experience preferred COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: * Ability to interact successfully within finance and cross-functionally, including influencing business leaders * Strong oral and written communication skills * Ability to multi-task and re-prioritize as necessary * Analytical and detail-oriented * Able to perform within tight deadlines in a fast-paced environment * Strong desire for continuous improvement; willingness to challenge status quo * Proficiency with Microsoft 365 (Excel especially) BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: * 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st * 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay * U.S. Employee Stock Purchase Plan- 15% Discount * Comprehensive Medical, Dental, Vision, Life and Disability coverage * Health, Dependent Care and Limited Purpose Flex Spending and HSA options * Adoption assistance * Tuition reimbursement * Concierge/personal assistance services * Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage * Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: * Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure * Risk IQ: Know what policies apply to your role and function and adhere to them. * Speak Up: If you see something, say something. Manager Obligations: * Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure * Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. * Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $72k-100k yearly est. Auto-Apply 51d ago
  • Account Director, Criminal Justice Systems (Southeast)

    Indivior 4.8company rating

    Remote Indivior job

    TITLE: Account Director, Criminal Justice Systems (Southeast) Title: Account Director, Criminal Justice Systems Reports To: Regional Director, Criminal Justice Systems Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: The Account Director will serve as the primary account manager within assigned criminal justice systems accounts. The Account Director will provide leadership to the assigned account and collaborate with key decision makers to represent the interests of Indivior and its entire portfolio and support Indivior by identifying and then developing new business opportunities in collaboration with the account or its affiliates. This role will work cross functionally with our sales stakeholders to evaluate and determine if local & national opportunities can and should be expanded system wide to drive business results, within assigned accounts. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: Provide Account Management, strategic planning and analysis to assigned institutional and/or integrated key accounts. Develop and implement comprehensive business plans for assigned accounts to ensure targeted growth of Indivior portfolio. Develop and maintain collaborative working relationships with, external stakeholder decision makers and account influencers within assigned accounts. Collaborate with Medical Affairs to ensure fair balanced delivery of all product value proposition presentations, clinical proofs, economic models, tools and other value add services are fully leveraged within assigned accounts. Accountable for achieving access, contractual, and outcome goals as agreed upon and identified in account generated business plans. Develop trusting and collaborative relationships with business unit Sales/Marketing Leadership, Global Market Access, Legal, and other internal Commercial Operations colleagues to execute on identified customer business plans. Partner with our field sales organizations for each account in driving sales and/or market share results synchronized with field sales performance goals, by clearly outlining and agreeing to appropriate pull-through opportunities with sales leadership. Identify and deliver on account point of view and priorities as part of market research, marketing planning and other internal planning processes. Ensure that all activities and interactions are carried out with the highest ethical and professional standards and that all work is accomplished with integrity and in accordance with Indivior Core Values and aligned to Market Access SOPs. Negotiate contracting and assure appropriate access of product and field team Carry out other reasonable tasks as required by the Line Manager. The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements. Work cross functionally with other Indivior business functions including Insupport and Channel Accounts to build account management foundation for Criminal Justice Systems MINIMUM QUALIFICATIONS: Education: MBA or advanced degree preferred. Undergraduate degree required in Science, Business, or other applicable field. Experience: 5-8 years in field sales with pharmaceutical Rx, medical, device company or specialty drug sales. 5-8 years as customer facing/account (hospital, payer, professional organization) role. Experience developing strategic account management plans within criminal justice systems. Understanding of the central contracting process as it applies to large health systems. Well-developed relationships with key decision makers and a thorough understanding of the potential assigned accounts. Specialty Injectable Product Experience and OHS Experience. EHR automation experience. Travel: 50% + COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Analytical ability to synthesize inputs from a range of sources in order to identify key market, account and customer insights. Ability to define and articulate financial, clinical and patient value. Long-term orientation, with a focus on building long-term sustainable relationships and revenue streams. Motivated by the desire to make a difference to the customer. Strong business acumen with ability to create and constantly impact business outcomes. Demonstrated knowledge of RWE & HEOR. Ability to manage complexity and ambiguity while adhering to Indivior's Guiding Principles. Demonstrates a deep customer-centric mentality through applied knowledge of the important drivers of the future landscape. Impeccable integrity and ability to conduct business in accordance with Indivior Core Values and Compliance policies. Ability to develop credible relationships at high levels within accounts. Ability to learn and apply scientific and clinical data with key accounts. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $84k-132k yearly est. Auto-Apply 11d ago
  • Quality Systems & OPEX Manager

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: Quality Systems & OPEX Manager Title: Quality Systems & OPEX Manager Reports To: Head, Quality Systems & OPEX Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: The Global Quality Systems and Operational Excellence (OPEX) Manager role is a key part of the global quality organization in establishing and maintaining Quality Systems and driving a “culture of quality” at Indivior. This is a key role in creating strategic plans with cross functional stakeholders to improve compliance and reduce risk in the Pharmaceutical Quality System (PQS). This role's focus will be to support the review and approval of all INDIVIOR GxP IT system change controls and validation documents, lead the product quality complaints process, and facilitate global Deviation and CAPA management to support the business. ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following: · Cross-functional influence to create strategic plans to ensure establishment and lifecycle management of a compliant Pharmaceutical Quality System (PQS) which contains over 100 cross-functional processes. · Oversee and action GxP IT systems change controls and validation documents such as quality assurance plans, test scripts and other documents as required; also supports technical transfer, testing, qualification and validation. · Write, review and/or approve validation protocols and reports. · Provides GxP IT support to INDIVIOR reviewing and approving IT change controls quality assurance plans and other validation records. · Participates in 3rd party validation planning meetings and communicates key information to INDIVIOR stakeholders as related to IT systems. · Lead the management and triage of product quality complaints. · Identify and report appropriate process and IT system metrics and trends to functional heads to drive compliance. Ability to interpret metrics and trends and based on this, identify areas of improvement. · Provide direct assistance to the Quality Operations teams for the resolution of quality events. · Act as a process owner for Quality Management System processes. · Act as IT system Superuser (if the process uses an IT system) and able to support and advise on IT system changes and carry out execution of test scripts when required. · Ensures compliance and reduced Regulatory risk in the PQS. · Ensures PQS processes are effective, enabling commercial product release supporting patient's markets supplied globally. · Provide direct oversight and influence for the PQS processes (where the Quality Systems team does not have Process Ownership) and work with stakeholders to identify and rectify compliance gaps and improvements. · Utilize continuous improvement methodology and deployment across functions to improve processes. This includes Lean Six-Sigma methodologies and project management. · Provide direct support for all related continuous improvement activities as applicable. · Assist Indivior Head, Quality Validation and Validation Manager in providing support in IT change management and validation activities that may impact product and/or process. · Assist in providing support for all GxP changes and additions to SOP, Work Instruction, specifications and like controlled documents. · Monitor and improve the health and execution of owned process(es) through metrics (process & IT system metrics) and other appropriate control measures, update the documentation periodically or as the process changes and ensure the relevant people are adequately trained for their role in the process. · Assist in providing training support for new and existing employees, as needed. · Participate in key regulatory inspections and readiness efforts internally and externally as required. · Any other duties as determined by management to support the Quality Systems and OPEX team. MINIMUM QUALIFICATIONS: License/Certifications: N/A Travel: minimum 10% · Bachelor of Science degree in a relevant scientific discipline from an accredited university required. · Proven track record, minimum eight (8) years of quality experience, in a regulated industry such as FDA regulated, pharmaceutical or medical device. · Broad knowledge of current GMPs, regulatory requirements related to international standards including GAMP5, EU, Health Canada, TGA, ICH, PIC/S. · Knowledge of sterile manufacturing. · Proficient in validation and qualification, risk assessments for equipment, facility and process. · Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks. Make and communicate appropriate judgments on any assessed risks to continue or suspend until risk can be mitigated. · Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action. · Excellent communication skills - presentation, written and oral. · Proven ability to work under pressure without compromising deliverables. · Collects, understands, interprets and trends data on the quality system performance. · Advanced computer skills including Microsoft platform and Visio. COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: · Proficiency in conducting Risk Assessments to support deviation investigations, change management and CAPA. · Highly skilled at training and coaching others in problem solving, root cause analysis and execution of improvements. · Advanced working knowledge of the electronic Quality systems used at INDIVIOR is an advantage (e.g. Veeva, SAP, Success Factors). · Excellent team player, able to work across boundaries to accomplish goals set. · Excellent interpersonal and communication skills and ability to communicate clearly to peers and senior management. · Influencing skills in areas with no direct reporting authority including senior management. · Logical, process-based thinking necessary to work effectively in role. · Able to understand different perspectives and deliver the best outcome for the global business. · Global role that works across all functions where there is GxP responsibility. Expected to travel to meet the needs of the role. · Green Belt certified in Lean Six-Sigma preferred. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $61k-95k yearly est. Auto-Apply 14d ago
  • Quality Operations Lead

    Indivior 4.8company rating

    Indivior job in Richmond, VA

    TITLE: Quality Operations Lead Title: Quality Operations Lead Reports To: Head of Quality Operations - North America Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit **************** to learn more. Connect with Indivior on LinkedIn by visiting ********************************** POSITION SUMMARY: This role is responsible to support Quality Operations in the US and Most of World for all Indivior Products. The Quality Operations Lead role is intended to support Quality Operations across all areas of Supply from Manufacturing, Packaging, Logistics for all Indivior Products. Quality Operations will ensure products are manufactured and packaged in full compliance with cGMP and regulatory requirements and supporting on-time delivery of patient supply to stakeholders in the US and Most of World. The scope of this role will also ensure compliance through maintenance of quality technical agreements, providing inspection/audit support, updating SOPs and work instructions, review and approval of product quality complaints, review of temperature excursions, lead and manage change controls, lead and execute CAPAs, execution change control action items, authoring deviations, and authoring risk assessments. Batch record review for manufacturing and secondary packaging may be required as necessary. If needed this role can also support commercial release for supply. This role will also be responsible to support operations of third party vendors through Supplier Quality Oversight and maintenance of all purchase requisitions. ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following: Understanding of all Indivior Products and their Supply Chain to enable Quality Operations support. Provide leadership, support and guidance to Indivior Quality Professionals in the US, EU, Canada, AuA and Most of World (MOW) to allow commercial release of Indivior Products. This involves liaising with CMOs, CPOs, 3PL to obtain product information to support Qualified Persons (QP) and Responsible Persons (RP) certification and ensure commercial release of Indivior Products. Author and maintain Quality Technical Agreements between Indivior, intracompany functions, CMOs/CPOs/3PL, external partners, and suppliers. Manage and create all purchase requisitions/purchase orders and on time payment of invoices for all NAQA external vendors, test labs, service providers, and suppliers Provide direct support for all inspection and audit activities. Assist in managing inspection activities. Support and or author responses to audits, inspections or health authority queries Lead and author deviations and perform the impact assessment, root cause analysis, and identify CAPAs Lead and author risk assessments, perform the impact assessment, rate the severity, likelihood, probability, risk score, identify risk mitigation strategies, and determine overall risk and conclusion/path forward Lead and manage change controls and CAPAs Perform impact assessments on change controls Execute change control action items Author and/or review SOPs, work instructions, protocols or job aids Review and approve deviations, change controls and CAPAs in the Indivior QMS system Review temperature data and author/approve Product Disposition Statements for Temperature Excursions Participate and/or Present in JOT meetings for CMOs, CPOs, Suppliers and all other Third Party Partners. The Quality Operations Lead is expected to create slides and collate data/KPIs, to present to evaluate performance and all other issues relevant to the discussion. Lead and manage continuous improvement activities and drive to completion Participate in the review, investigations and responses for product quality complaints. Review manufacturing and packaging batch records as required to support product disposition Assist in providing training support for new and existing employees. Ensure that Annual Product Reviews have been completed by responsible parties and have been assessed internally against requirements and are delivered according to schedule. Any other duties as determined by management to support North America Quality Operations Team MINIMUM QUALIFICATIONS: License/Certifications: N/A Travel: Minimum 10% Bachelor of Science degree in a relevant scientific discipline from an accredited university required. Proven track record, minimum five (5) years of quality experience, in a regulated industry such as FDA, pharmaceutical or medical device. Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S. Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks. Make and communicate appropriate judgments on any assessed risks to continue or suspend until risk can be mitigated. Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action. Excellent communication skills - presentation, written and oral. Proven ability to work under pressure without compromising deliverables. Must be comfortable working in a team environment or working independently under minimal supervision. Collects, understands, interprets and trends data on the quality system performance. Strong computer skills including SAP, Veeva, TrackWise, Microsoft Office Suites, MS Project, MS Copilot, must be adept in learning and using new technology as it relates to the professional work environment COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Adherence to Indivior Guiding Principles Adherence to the Indivior Code of Conduct BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes: 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled
    $67k-93k yearly est. Auto-Apply 60d+ ago

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Indivior may also be known as or be related to Indivior, Indivior Inc and Indivior Plc.