Quality Manager jobs at Bristol-Myers Squibb

STAQ is currently hiring for a Quality Control Manager in the Denver area Monday to Friday, 8 AM to 5 PM Salary: $105K-$110K/year STAQ Pharma is a 503B Outsourcing Facility located in Denver. STAQ Pharma produces sterile injectable medications for adults and pediatric patients, compounded under cGMP standards. STAQ's ownership and board are composed of large hospital systems ensuring the priority focus remains on delivering needed medications in a safe and timely manner. We are looking for exception people to join the STAQ team. This role is responsible for leading all Quality Control (QC) activities at the site. The QC Manager will encourage and motivate associates to be successful and focused on Safety, Transparency, Availability, and Quality (STAQ) objectives. Roles and Responsibilities Establish an environmental monitoring program for the facility utilizing a risk-based approach to new and existing procedures. Develop, manage, and improve QC processes and procedures to ensure compliance with all applicable laws, regulations, and STAQ Quality standards in support of cGMP standards for pharmaceutical manufacturing (503B). Prepare, review, manage, and approve controlled documents (SOPs, protocols, logbooks, reports, etc.) relevant to STAQ QC operations. Lead and draft investigations/deviations/change controls/OOS/CAPAs as they relate to environmental monitoring or Quality Control deviations. Provide expertise and support to the Operations, Regulatory, and Quality teams. Subject matter expert during audits or inspections as it relates to microbiology/environmental monitoring. Recruit, retain, and mentor direct reports to comprise the QC team. Promote personal and professional growth of team members. Support the batch disposition process including management of reserve samples and QC samples for batch release testing. Manage the budget for the QC Lab department to meet financial objectives. Lead the Stability Program including study management, protocol development & evaluation, timely completion of stability tests, data trending, etc. Collect, submit, ship, and manage appropriate raw material, microbiological and finished goods samples to third party testing laboratories. Coordinate and facilitate operations within the internal laboratory to ensure Environmental Monitoring samples are performed, tested, reviewed, and trended appropriately. Conduct routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility. Analyze and interpret trends and identify opportunities to improve processes and achieve state of control. Focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up, and ability to make timely and sound decisions. Implement methods of continuous improvement in daily work and in evaluation of company processes and performance. Other duties as assigned. Preferred Qualifications and Education B.S. or B.A. in Microbiology or a closely related field / or equivalent experience. Minimum five (5) years' experience in a quality control environment. Experience in a cGMP pharmaceutical/aseptic manufacturing environment. Must demonstrate understanding and/or working knowledge of regulations/guidelines such as FDA, USP, ICH, etc. Proficiency/experience with environmental monitoring program for aseptic manufacturing facility, including personnel monitoring, and qualification program. Preferred Experience and Skills Working knowledge of aseptic/sterile manufacturing techniques. Ability to coordinate multiple priorities in a fast-paced environment. Strong communication skills with the ability to interact with all levels across the organization. Demonstrated excellent interpersonal skills and flexibility. Familiarity with 21 CFR Part 11/210/211. Additional Notes Join a dynamic team at the leading edge as we build out a new 137K sq. ft. manufacturing facility. This position will work closely with cross functional teams and report quality data to the department heads for each team, as needed Timeline: We will be accepting applications on an ongoing basis until position is filled.

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised. All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP. ACCOUNTABILITIES Regulatory Compliance: (15%) Stays current with federal, state, local and company-specific rules, regulations, and practices. Ensures center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety. Ensures that SOP's are current and that staff perform routine tasks according to SOP through direct observation. Plasma Collection Center Quality Assurance Oversight: (80%) Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements. Tracks deviations and trending in operating procedures and policies through established mechanisms. Reports errors, deficiencies, discrepancies and observations to center management and the Regional Quality Manager. May stop operations or shipments when donor or product safety is or may be compromised. Identifies potential SOP revisions as needed to support continuous improvement. Works in collaboration with center manager and management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of audit observations. Tracks responses to and evaluates effectiveness of corrective actions for errors. Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program. Coordinates management review meetings and participates in center staff meetings. Employee Recruitment and Retention: (5%) Responsible for providing feedback and developing employees in the quality department. Provides feedback during the recruitment process for quality department employees, including performance evaluations and merit increases. Fosters teamwork. Works collaboratively with staff, peers, and management to achieve business goals. Communicates continuously and resolves conflicts proactively. Provides timely feedback on performance and initiates disciplinary action when necessary. Participates in the evaluation and review of center staff. Ensures high levels of customer service and satisfaction. Meets and strives to exceed customer expectations. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Minimum of one-year relevant work experience, or an equivalent combination of education and experience. Relevant work experience within medical or regulated field, highly desirable. Previous work experience within the plasma collection industry is strongly preferred. Computer skills in word processing, excel, data analysis and databases highly desirable. Demonstrated understanding of quality assurance in an FDA-regulated environment. Demonstrated understanding of plasma center operations. Effective organizational, technical and problem-solving skills. Leadership Integrity Fairness Honesty Perseverance Putting the patient at the center Building trust with society Reinforcing our reputation Developing the business Decision-making and Autonomy Responsible for providing exceptional customer service to donors (external) and fellow employees (internal) Refers to Group/Regional Lead for guidance on complex, high-impact or urgent decisions (internal) Refers to management team for escalated donor/employee concerns (internal) Interaction Consults and coordinates directly with the Center Manager on quality concerns within the plasma center. Advises and coordinates will all other center roles to effectively problem solve, mitigate risk, ensure safety of staff and donors, and provide an exceptional customer experience. Attend staff meetings and other team meetings as required. Attention to detail and ability to work independently Effective coaching and counseling skills. Innovation May participate in the management of projects and new initiatives within the center or across centers. Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience. Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen). Complexity Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment. Production environment oversight. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Essential: High School Diploma or equivalent required. Desired: Associates or Bachelor's degree highly desirable. ADDITIONAL INFORMATION FLSA Classification (US) - Exempt Other duties and responsibilities as assigned. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NY - Latham U.S. Base Salary Range: The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - NY - LathamWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt Yes

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. POSITION SUMMARY: The Director, Quality Assurance (GCP) oversees the development, implementation, maintenance, and performance of GCP Quality Assurance systems both within company and external vendors. The Director will execute and/or ensure proper oversight of the GCP QA audit program management, clinical operations phase 1 to phase 4 study team support, regulatory inspections, and GCP QA infrastructure development. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These may include but are not limited to: General Provide GCP quality assurance strategy and oversight of QA GCP operations Ensures that clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies Develop and implement risk management strategies to identify, assess, and mitigate risks Drive effective initiatives that foster a culture of quality and continuous improvement Successfully collaborate on multiple projects with cross-functional stakeholders Lead investigations of significant complexity Prepare and present to executive management Manage, lead, and mentor quality assurance team members; lead cross-functional teams on compliance projects Audit Management Develop a plan with CROs for clinical sites' audit execution Manage clinical site, TMF, and GCP and GLP vendor audit activities Generate and/or review and approve overall GCP QA audit plans and schedules Generate and/or review and approve audit trend reports Execute the GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends Study Team Support & Issue Escalation Management Represent QA at program-wide (e.g., study team or governance) meetings and provide GCP guidance and feedback Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads, and responsible for informing the head of QA and Management, as required Manage quality events, CAPAs, and deviations Collaborate with cross-functional teams (Clinical Operations, Clinical Research, Regulatory, etc.) to embed quality by design in clinical programs. Provide guidance and support to Trial Master File activities Quality Systems / Inspections / Infrastructure Ensure adequate systems and controls are in place for GCP compliance Identify and address quality systems gaps, including internal processes and personnel GCP training Execute the review of GCP SOP tracking and status reports to ensure timely review and development of SOPs Author, review, or revise SOPs related to clinical and non-clinical studies Develop and provide GCP training Support regulatory inspection activities and GCP inspection readiness activities Prepare internal team, clinical sites, and vendors for inspection readiness Thoroughly review clinical study documents Perform breach assessments Oversee quality vendor management and governance for GCP and GLP vendors Review Quality Agreements to ensure clear delineation of responsibilities and compliance expectations between the sponsor and the vendor Contribute and present GCP quality events and metrics at the Quality Management Review meeting Support other Quality Assurance and Quality Systems activities Other duties as assigned. Education and Experience Required: Minimum Bachelor's degree in a science discipline and at least 12 years' experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered) Minimum of 8 years of working in a GCP QA function Previous experience leading inspection readiness and audits Thorough understanding of FDA, EU and local regulations, as well as understanding of ICH guidelines Hands-on experience in developing and implementing GCP procedures Strong working knowledge of GCP and GLP regulations Proven ability to cultivate and develop relationships with cross functional teams and vendors Demonstrated leadership ability to identify, manage and develop QA teams Must be able to make critical and strategic decisions based on risk-assessments Capable of managing multiple projects simultaneously Excellent communication and listening skills Preferred: Auditing certification is a plus Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 10% of your time. The Anticipated Base Salary Range: $176,000 - $220,000 In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Vaccination requirement: Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation. Salary Range The salary range for this position is: $180,000 - $225,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

Non-Solicitation Policy and Notice to Agencies and Recruiters: IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to ****************************. We ask that you only email your interest once. Job Summary About IDEAYA Biosciences: IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see ****************** Location: South San Francisco, CA. Position Summary: We are seeking a Director of Good Clinical Practice Quality Assurance to join our IDEAYA Quality Team. The Director of GCP QA is a leadership role responsible for overseeing the quality assurance activities related to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP). This role is responsible for ensuring compliance with global regulatory requirements, industry standards, and company policies related to clinical trials. The candidate will provide strategic leadership, drive continuous improvement initiatives, accountable for quality oversight of contract organizations, and ensure the highest standards of quality and patient safety in clinical research activities. The candidate will represent QA and function as the GCP QA lead and accountable for Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP) oversight for all Ideaya Bio. clinical studies. This position will report to the Vice President, Quality. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy. Job Description What you'll do: Lead and manage GCP audits, including clinical investigator sites, vendors, clinical trial documentation, and internal processes. Host and support regulatory inspections (i.e., BIMO, PV), partner audits and due diligence activities ensuring inspection readiness and timely resolution of findings. Review and approve audit reports, CAPA and quality action plans, and follow-up actions to ensure effective resolution of non-conformance and quality events. Develop and implement the global GCP QA strategy aligned with corporate goals, Ideaya SOPs and global regulatory requirements. Function as the Clinical QA Lead on all Ideaya Clinical study, represent QA in joint and steering committees including making key decisions on all GCP events. Oversee the development, implementation, and maintenance of GCP QA policies, procedures, and systems. Support the development and review of clinical trial protocols, informed consent forms, and other critical study related documents. Review and approve key documents, study protocol, monitoring plans, contracts and all study related essential documents. Ensure Ideaya clinical studies are in compliance with global GCP regulations (e.g., FDA, EMA, ICH E6 R2/R3) and company standards. Compile, track GCP quality metrics (KPI) and vendor performance on all Ideaya initiated clinical studies and report to management on a quarterly basis. Identify, assess, and mitigate GLP/GCP-related compliance risks across clinical development programs including escalation of critical quality events to sr. management. Collaborate with clinical operations, regulatory affairs, and other stakeholders to address quality events and drive continuous improvement. Partner with clinical development, regulatory affairs, pharmacovigilance, and other functions to ensure alignment on quality and compliance objectives. Partner with clinical operations in selection of CRO's and other clinical service providers including managing the qualification and ongoing monitoring of GCP vendors, including CROs, central labs, and clinical service providers. Ensure contract research vendor compliance with contractual obligations, agreements, and regulatory requirements. Build, mentor, and lead a high-performing GCP QA team. Provide training and development opportunities to enhance team capabilities. Foster a culture of quality, accountability, and collaboration within the team and across the organization. Provide expert guidance on GCP regulations, guidance and compliance to senior management and cross-functional teams. Requirements: Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred). Minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with at least 10 years' experience working in GCP QA or clinical quality leadership roles. Minimum of 5+ years' experience hosting regulatory BIMO inspections (e.g., FDA, EMA, PMDA) and managing GCP audit programs. Proven track record and relevant industry experience in leading GCP QA functions within a global organization, preferably in oncology. Strong knowledge of global GCP regulations, ICH guidelines, and clinical trial processes. Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels. Analytical thinker with a focus on continuous improvement and innovation. This role may require occasional travel (up to 20%) for audits, inspections, and meetings. Flexibility to work in a fast-paced, dynamic environment with evolving priorities. Must be able to effectively collaborate with peers and comfortable working in a matrix team structure. Preferred Skills: Preferred background of oncology and/or early phase R&D Total Rewards Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs. The expected salary range for the role of Director, Good Clinical Practice Quality Assurance is $193,000- $238,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates' experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process. The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite in the office at the Company's facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization. IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

Non-Solicitation Policy and Notice to Agencies and Recruiters: IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to ****************************. We ask that you only email your interest once. Job Summary About IDEAYA Biosciences: IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see ****************** Location: South San Francisco, CA. Position Summary: We are seeking a Director of Good Manufacturing Practices and Computer System Validation Quality Assurance to join our IDEAYA Quality team. The Director, GMP & CSV QA is a leadership role responsible for developing and maintaining Good Manufacturing Practices (GMP) and Computer System Validation (CSV) Quality Systems as well as supporting internal and external compliance activities. Direct responsibility, authority, and accountability for the Deviation, Corrective Action/Preventive Action (CAPA), Change Control, and Batch Release Systems. Responsibilities will also include acting as QA liaison to various project teams. The candidate will ensure compliance with regulatory requirements, industry standards, and company policies for the manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). The Director will provide strategic leadership, drive continuous improvement initiatives, provide quality oversight of contract organizations, and ensure the highest standards of product quality and patient safety. This position will report to the Vice President, Quality. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy. Job Description What you'll do: Develop and implement the global GMP & CSV QA strategy aligned with corporate goals, Ideaya SOPs and global regulatory requirements. Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards. Develop procedures and work flows to define key Quality Systems including Deviation, CAPA, Change Control and Document management. Ensure that cGMP departments and Operating units within Ideaya have written procedures to support GxP activities. Oversee the development, implementation, and maintenance of GMP QA policies, quality agreements, standard operating procedures, and quality systems processes and workflows to manage quality events. Manage and oversee all aspects of GxP quality functions for clinical and commercial products i.e., Lot Release, Quality Systems records (i.e., Deviations, Change Control, Complaints, Audits, Product Quality Review). Monitor emerging regulatory trends and ensure proactive adaptation of QA processes. Compile, track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis. Lead and manage GMP audits programs (internal and external), including manufacturing sites, contract manufacturers and packagers, suppliers, and laboratories. Host and support regulatory inspections, ensuring inspection readiness and timely resolution of findings. Represent GMP QA in regulatory inspections, partner audits, and due diligence activities. Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events. Lead or oversee the annual product quality review (APQR) process to ensure ongoing evaluation of product quality and compliance. Drive continuous improvement initiatives based on key performance indicators (KPIs), APQR findings and trends. Identify, assess, and mitigate GMP-related risks across the supply chain (end to end), GMP vendors and manufacturing processes. Provide expert guidance on GMP & CSV compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management. Collaborate with manufacturing, supply chain, regulatory affairs, and other stakeholders to address quality issues and drive continuous improvement. Build, mentor, and lead a high-performing GMP & CSV QA team. Foster a culture of quality, accountability, and collaboration within the team and across the organization. Partner with CMC, regulatory affairs, IT and R&D to ensure alignment on quality and compliance objectives. Support the development and review of batch records, specifications, test methods, protocols, and other critical documents. Oversee the selection, qualification, and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories. Ensure vendor compliance with contractual obligations, quality agreements and regulatory requirements. Requirements: Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred). Minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with at least 8 years in GMP QA or manufacturing quality roles working in a firm with in-house manufacturing. Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fast-paced, dynamic environment with evolving priorities. Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes. Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs. Exceptional leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities. Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels. Strategic thinker with a focus on continuous improvement and innovation. This role may require occasional travel (up to 20%) for audits, inspections, and meetings. Preferred Skills: Prior supervisory or function management experience is required. Total Rewards Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs. The expected salary range for the role of Director, Good Manufacturing Practices & Computer System Validation Quality Assurance is $187,000 - $231,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates' experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process. The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite in the office at the Company's facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization. IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

Do you have expertise in, and passion for Quality? Would you like to apply your expertise influencing strategic directions on quality and compliance being the GVP/GCP expert related to clinical and post-market activities in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. We are now recruiting for a Director Strategic Advice position to join our Strategic Advice team within R&D Quality Assurance. R&D QA is an independent global quality assurance function in AstraZeneca R&D maintaining the R&D Quality Management System and assessing quality based audits, inspections and self-reported quality issues. We promote and strive towards a state where everyone acknowledges that quality is a competitive advantage, and that quality arises from every individual's contribution to a ‘right-from-me' mentality. If you enjoy challenging the way things are done and want to pioneer a new future to meet global healthcare challenges this is the place for you. This position is based out of our Gaithersburg, MD office and will follow a hybrid work schedule. What you'll do Work closely with stakeholders in R&D providing leadership in influencing strategic direction on quality and compliance through responsive and proactive GCP/GVP expert advice related to clinical and post-market activities including risk management. Deliver end-to-end regulatory inspection strategy and management. Manage business relationships with defined stakeholder groups and senior leaders in R&D, and for the strategic development and delivery of a GxP risk-based robust quality assurance program and quality management activities for these stakeholders. Lead or participate in the investigation of critical quality issues and ensure timely reporting of issues to relevant authorities, where applicable. Lead training for colleagues and business stakeholders. Support or lead the development and/or revision of QA processes, projects, and tools. Generate simple solutions to complex challenges while having a ‘solutions focused' attitude. Essential for the role Bachelor's degree required, Master level degreed preferred 10+ years experience in pharmaceuticals or a related life-science industry required A thorough understanding and experience of GxP (GVP and GCP) and quality assurance/management Strong collaborative, influencing, and interpersonal skills, curious to understand business environment Excellent analytical, written and oral communications skills Proficient in written and spoken English High ethical standards, trustworthy, operating with absolute discretion Skilled at managing & using technology, curious regarding AI Ability to maintain and create professional networks with stakeholders Experience in managing regulatory health authority GxP Inspections Desirable for the role Project management Key Account management Experience in Six Sigma/Lean/Process improvement tools Quality and Audit expertise What you can expect: great working atmosphere empowering you to reach your full potential, endless development opportunities and benefits like: medical & life insurance, annual bonus, education cost reimbursement, occasional allowances (Christmas, holiday), anniversary awards, additional time off, pension plan, business travel insurance, recognition program, flexible working hours. Why AstraZeneca? At AstraZeneca you will be valued. Not only for your unique contribution, skills and background, but because we recognize people are our greatest asset. Here we are dedicated to being a Great Place to Work. Thrive in an energizing environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there's no better place to unlock learning and build a long-term career. Most importantly, we do meaningful work that changes lives. It's our purpose that drives us, every day. Interested? Come and join our journey. The annual base pay for this position ranges from $150,227.20 - $225,340.80 USD. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 26-Nov-2025 Closing Date 11-Dec-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

The Director, GDP Operational Quality is responsible to partner with Trade Operations to support the distribution of Vertex's commercial product portfolio. The role is responsible for oversight of team activities, development of personnel and ensuring timely completion and quality of deliverables/goals within their remit. The role supports GDP quality operations for all distribution activities within the US; key stakeholders include Trade Operations, Vendor Quality Management & Quality Compliance. Key Duties and Responsibilities: The responsibilities of this position may include, but are not limited to, the following: * Primary quality partner for Vertex US Trade Operations organization, providing quality input and perspective to US Trade Ops continuous improvement initiatives and projects * Accountable for ensuring US Trade Ops organisation are operating within the Vertex GDP Quality Management System, accountable to ensure deviations are investigated, recorded in the QMS and CAPAs are identified. * Establish robust Quality Processes/Process Ownership for the distribution of Vertex Commercial Finished Goods within the US * Responsible for local release activities required to support distribution of Vertex Commercial products * Support Trade Operations with Risk Management activities * Support the Shipping, Storage & Distribution (SS&D) Process Owners Network (PON). Build, maintain and drive and manage PON activities set out in the SS&D Roadmap * Responsible for the Quality oversight and management of Vertex strategic US third party logistics providers : creating and maintaining Quality Agreements, developing KPIs, establishing Quality meetings and participating in governance forums * Support inspection preparation and management, prior to, during and following any Authority inspection; Support manufacturing locations as required. * Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; recommend mitigation approaches. * Participate in New Product Launch activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g., QMS build out, audits, and Quality Agreements. * Act as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions. * Develop, utilize and continue to mature tools to ensure efficiency in execution of Distribution Quality Processes Qualifications/Requirements/Skills: * GDP & GMP work experience, or relevant comparable background. * Expert knowledge of International GDP regulations; broad knowledge of GMP and GVP regulations, * Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical environment. * Demonstrated capability to lead a team through organisational change and a dynamic/ evolving business model. * Proven leadership ability to design/evolve and implement quality strategies to support their commercial and supply chain partners in both a clinical and commercial setting. * Strong ability to collaborate cross functionally across all levels of the organization with strong communication skills and the ability to persuade others to adopt a new point of view, achieve consensus and negotiate effectively, * Highly skilled at managing change, and driving Continuous Process improvements, * Highly skilled at time and resource management, prioritization of own work and departmental initiatives, and planning/organization skills, * Highly skilled in technical writing, * Demonstrates advanced ability to effectively communicate to local, international and global audiences, * Significant experience in managing/leading others to include performance management and career development, * Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions * Demonstrates the Vertex behaviours. * Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint). Education and Experience: * Bachelors degree in a scientific or allied health field * Typically requires 10 years of relevant work experience, or the equivalent combination of education and experience We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work: 1. Hybrid and work remotely up to two days per week; or select 2. On-Site and work 5 days per week with ad hoc flexibility. #LI-AR1 #LI-Hybrid Pay Range: $182,400 - $273,500 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Job Family for Posting: Quality Job Type for Job Posting: Full Time Apply now * Apply Now * Start applying with LinkedIn Start Please wait... About Us Innovation. Sustainability. Productivity. This is how we are Breaking New Ground in our mission to sustainably advance the noble work of farmers and builders everywhere. With a growing global population and increased demands on resources, our products are instrumental to feeding and sheltering the world. From developing products that run on alternative power to productivity-enhancing precision tech, we are delivering solutions that benefit people - and they are possible thanks to people like you. If the opportunity to build your skills as part of a collaborative, global team excites you, you're in the right place. Grow a Career. Build a Future! Be part of this company at the forefront of agriculture and construction, that passionately innovates to drive customer efficiency and success. And we know innovation can't happen without collaboration. So, everything we do at CNH Industrial is about reaching new heights as one team, always delivering for the good of our customers. Job Purpose In this role, you will be responsible for customer quality experience and solutions implementation for Precision Technology (PT) products and machine functionality on Agricultural Equipment within North America Region. This role manages a team of Customer Quality specialists/engineers focused on early identification of product quality and behavior issues, rapid field containment of quality issues, and resolving complex technical support problems (THD Level 2/3) as well as accurate documentation and communicating of issues to global Digital/Precision Solutions team for resolution and incorporation into new and current product. Champion of voice of NA customer in Current Product Management process. The selected individual will define regional customer acceptance criteria for new product, based on regional needs and collaborate proactively across Quality functions and Product Platforms respective of the integrated and inter-reliant nature of advanced agricultural machinery and Precision Technologies (PT). Additionally, this role will support and coordinate with Global Product Platforms (GPP), Digital Solutions Product Management, Global Quality Leaders and Brand Management to improve customer driven solutions to regional product issues. Tracking product performance in the field, identifying the key technical issues to be resolved and driving the root cause analysis and resolution process in collaboration with Global Precision Technologies Quality and Customer Success team. Key Responsibilities * Develop and grow North America field quality and customer experience team. * Eliminate inefficiency and bureaucracy in problem solving process to quickly provide customers with robust solutions. * Reduce the time to identify current product issues and improve root cause analysis to support reduction in time to fix and improve solution effectiveness. * Manage the identification and validation of field containment actions for key product issues. * Understand local market requirements and provide the Voice of the Customer to correctly prioritize field Quality & Reliability issues during Early Warning and Current Product Management (CPM) activities. * PIP (Product Improvement Program) Management - identification and proposal for region management financial approval, reducing cycle time from submission to dealer release. * Implement strategic field actions and product improvements tied to Net Promoter Scoring on key product lines. * Analyze and manage Quality-focused Customer Survey Red Alerts and necessary follow-up. * Responsible for Product Quality results on Dealer Satisfaction Survey and execution of internal and external actions intended to address Dealer Satisfaction issues, and promote improved satisfaction across network. * Track and manage Warranty KPI ($ACPU and CORF F/100) and implement actions to achieve improvements in both aligned with budget and multi-year strategic business plans. * OK to Sell approval for new products launched into the region * Region management of Early Warning activities for New Product Launches - validation, concern resolution * Responsible for management, interaction and regular communication with the Region Brand organizations (Case IH and New Holland Field Service Teams, Dealer Advisory Councils, etc) on Top Product Issues & CPM worklists. * Manage the voice and promotion of the company's customer driven image in all Service Communication to boost dealer engagement and partnership, customer satisfaction and brand loyalty Experience Required * Bachelor's degree in relevant discipline. * Minimum 10 years of relevant experience. Preferred Qualifications * Proficiency in MS Excel and SAP ERP (FI-CO). * Business Intelligence and or Statistics experience (Cognos, Qlik, Access) is a plus. Pay Transparency The annual salary for this role is USD $134,000 - $196,000 plus any applicable bonus (Actual salaries will vary and will be based on various factors, such as skill, experience and qualification for the role.) What We Offer We offer dynamic career opportunities across an international landscape. As an equal opportunity employer, we are committed to delivering value for all our employees and fostering a culture of respect. At CNH, we understand that the best solutions come from the diverse experiences and skills of our people. Here, you will be empowered to grow your career, to follow your passion, and help build a better future. To support our employees, we offer regional comprehensive benefits, including: * Flexible work arrangements * Savings & Retirement benefits * Tuition reimbursement * Parental leave * Adoption assistance * Fertility & Family building support * Employee Assistance Programs * Charitable contribution matching and Volunteer Time Off Apply now * Apply Now * Start applying with LinkedIn Start Please wait... {{video.content.cta}} {{video.content.title}} {{video.content.description}} × {{explore.title}} {{explore.description}} {{feed.title["#text"]}} {{feed.city["#text"]}}, {{feed.country["#text"]}} {{explore.cta}}

Zoetis Reference Laboratories Quality Manager, East Region Hybrid - Onsite in Louisville and potential for remote days The ZRL Quality Manager will carry out the important role of overseeing the Quality Management System for the East Region, including spoke labs and the Louisville location (ZRL's largest hub laboratory). Responsibilities will include training staff on the QMS and topics related to quality, non-conforming event (NCE) management, internal auditing, document control, policy/SOP writing, quality metric compilation/reporting, liaising with key leaders in other parts of the organization (e.g., medical, customer service, operations) and other quality related duties as assigned. The non-conforming event management duties will include triaging and tracking reported non-conforming events and working with all levels of ZRL staff to ensure timely, appropriate and effective investigation and implementation of corrective/preventive actions (CAPAs). The Quality Manager will carry out investigations and formulate/implement CAPAs for non-technical issues as assigned and work with technical staff to ensure appropriate issue resolution. Job Duties: Triaging, tracking and resolving reported non-conforming events Training staff on Quality Management System and topics related to quality Compilation and reporting of quality metrics Internal auditing, on location in Louisville and traveling to other ZRL labs Writing policies/SOPs and Document Control Duties Other duties as assigned Education/Experience: Bachelor's degree in a natural science (biology, vet science, chemistry, biochemistry, etc) is required. At least three (3) years' experience in Quality Assurance related role required. At least one (1) year on the bench in a veterinary or clinical laboratory required. Experience in Non-conforming Event Management (investigations, root cause analysis and CAPAs), SOP/policy writing, quality metric development/reporting and internal auditing preferred. Training in systems thinking and/or Just Culture preferred. Certification as MLS/MT/MLS/CLS, ISO auditor and/or ASQ preferred. Technical Skills Required: Proficient in Microsoft Office and internet required. Relationship building and cross functional collaboration Effective oral and written communication Indirect leadership and ability to influence change Preferred skills: Experience configuring and using compliance software (MediaLab is utilized) Excel, Power BI and/or other similar software to perform statistical analyses and produce metric reports and dashboards Internal auditing and delivering summary reports Physical Position Requirements: Ability to sit/stand/walk for long periods of time Occasional domestic travel required Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. Ensures Quality Assurance goals and objectives are identified and met Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelors' degree in Life Science or equivalent course of study is required. 10 years progressive experience in QA Pharmaceutical environment required. 5-10 years management experience required. Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. Excellent oral and written communication skills including strong technical writing skills. Strong organizational skills, planning skills and team-building. Ability to work independently and deliver timely results. Ability to lead cross functional teams, resolve conflicts and disagreements. Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. * Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. * Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. * Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. * Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. * Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. * Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. * Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. * Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. * Ensures Quality Assurance goals and objectives are identified and met * Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director * Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Bachelors' degree in Life Science or equivalent course of study is required. * 10 years progressive experience in QA Pharmaceutical environment required. * 5-10 years management experience required. * Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. * Excellent oral and written communication skills including strong technical writing skills. * Strong organizational skills, planning skills and team-building. * Ability to work independently and deliver timely results. * Ability to lead cross functional teams, resolve conflicts and disagreements. * Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions · Independently conduct audits · Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits · Facilitate Sponsor health authority inspections of global clinical facilities and study sites · Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs · Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. · May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements · Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. · 5+ years of experience in GCP auditing. · Substantial experience in inspection management. · Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. · Demonstrated ability to operate and influence decision-making processes · Effective communication skills · Successful track record of supervising employees and managing cross-cultural differences · Technical and administrative capabilities to independently carry out routine, complex and for-cause audits · Knowledge of data integrity controls and systems quality for clinical area · Strong analytical skills and report writing skills · Experience with GxP systems including computer system validation and associated regulations, recommended. · Ability to Travel (approximately 20%) · Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

The Quality Control Manager provides scientific leadership and technical oversight for all analytical operations supporting Pharmaceutical (Rx), Over-the-Counter (OTC), and Cosmetic products. This role ensures laboratory compliance with FDA 21 CFR Parts 210/211, ICH Q7-Q10, USP/NF, and MoCRA standards. The QC Manager is accountable for analytical accuracy, data integrity, and inspection readiness across raw material, in-process, finished product, and stability testing programs. The position also drives the implementation of risk-based testing, method lifecycle management, and data-driven process improvements aligned with site and corporate Quality objectives. Reporting to: Sr. Manager, Laboratory Services (QC) Location: Johnson City, TN - 100% onsite Responsibilities/Essential Duties: Leadership & Staff Development Lead, mentor, and develop QC Supervisors, Chemists, and Analysts through structured training and technical coaching. Maintain current training matrices, instrument qualifications, and competency assessments. Support succession planning, performance evaluations, and individual development plans. Promote a culture of scientific excellence, ownership, and regulatory compliance. Laboratory Operations & Technical Oversight Lead and schedule all QC testing activities for raw materials, in-process, finished goods, and stability samples. Ensure testing is performed per validated or verified methods (HPLC, GC, UV-Vis, FTIR, ICP-OES/MS, KF, TOC, pH, viscosity, etc.). Review and approve analytical data, chromatographic integrations, system suitability results, and trend analyses in accordance with ALCOA+ principles. Manage daily priorities to support batch release, stability commitments, and regulatory submissions. Support product investigations, method transfers, and laboratory deviation resolution. Regulatory Compliance & Data Integrity Maintain full compliance with cGMP, ICH, USP, EP, and MoCRA standards. Implement data-integrity governance across OpenLab CDS, iStability, and electronic record systems (audit trails, user access, instrument logbooks). Ensure accuracy, contemporaneous documentation, and traceability for all analytical activities. Author and maintain laboratory SOPs, validation protocols, and technical reports. Act as QC representative during internal, corporate, and FDA inspections, ensuring readiness and timely response to observations. Method & Raw Material Management Oversee method validation, verification, and transfer activities following ICH Q2(R2). Evaluate method robustness, linearity, accuracy, precision, and detection limits; author and review validation summary reports. Manage raw material qualification and release under 21 CFR 211.84, approving supplier CoAs and verification results. Develop risk-based sampling and testing plans for excipients, APIs, and packaging components. Maintain method equivalency and harmonization across contract and sister-site laboratories. Stability & Product Trending Administer the site stability program per ICH Q1A-Q1F, including pull scheduling, testing, and reporting. Review trend charts, regression analyses, and control charts to identify OOT behavior before specification limits are breached. Author or review stability summary reports, OOS/OOT investigations, and risk assessments supporting expiry dating. Ensure timely reporting and electronic data archiving per retention policy. Equipment & Analytical Technology Oversee qualification, calibration, and PM of analytical instruments (HPLC/UPLC, GC, FTIR, ICP-MS/OES, UV-Vis, KF, balances, ovens). Maintain validated status of computerized systems under 21 CFR Part 11 and Annex 11. Support CAPEX planning, URS/FAT/SAT/IOQ/PQ execution, and implementation of new technologies (e.g., autosamplers, LIMS integration). Approve equipment change controls and ensure adherence to life-cycle validation protocols. Quality Systems & Continuous Improvement Own and manage OOS, OOT, Deviation, NCM, CAPA, and Change Control processes. Participate in Quality Review Boards, CAPA Effectiveness Reviews, and Risk Assessments (FMEA, 5-Why, Fishbone). Develop and monitor Key Performance Indicators (KPIs) such as Right-First-Time, CAPA timeliness, and laboratory cycle time. Lead continuous-improvement initiatives focused on method robustness, cycle-time reduction, and Cost of Quality (CoQ) optimization. Basic Qualifications: Bachelor's degree & 7+ years' directly related experience. Preferred Qualifications: Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. Advanced degree. 7-10 years in a cGMP Qc laboratory; minimum 3-5 years in management or supervision. Hands-on experience in method validation, stability programs, analytical troubleshooting, and regulatory audits. Proven knowledge of FDA, ICH, USP/NF, and MoCRA regulatory frameworks. Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: Competitive Compensation including base salary and annual performance bonus. Flexible PTO, holidays, and parental leave. Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more! This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

The QC Manager will report to the Site QC Lead and be responsible to supervise and lead the Laboratory release function including Raw Materials, Intermediates, DPI and API's (including the stability program) and In Process Control and provide core technical support in areas of chromatography, investigations/deviations, troubleshooting, instrument calibration/qualification, and regulatory requirements. The QC Manager will provide a strong degree of technical and compliance leadership within the QC function as well as driving Quality System improvements and operational efficiencies within the lab and representing the Quality Department at meetings both on and offsite. The QC Manager will also be involved in the training, coaching and development of QC Analysts and have input to performance review and assessment. POSITION RESPONSIBILITIES Key objectives of this position include: 1. Leading the QC Area in the Laboratory, providing direction, leadership and support. 2. Laboratory investigations / deviations Chromatography & general Analytical troubleshooting. 3. Laboratory Documentation review (including documentation RFT improvement). 4. Planning and Scheduling of Laboratory Testing Activities, Equipment qualification / calibration oversight. 5. Ensuring Compliance of Laboratory Systems with current regulatory requirements. 6. Approval and Disposition of Raw Materials, IPC, Intermediate, Water and Environmental Monitoring and Stability Samples Collection, 7. Review and Approval of Data for CPV and APR's Continuous improvement / operational excellence activities including Laboratory 5S and Lean Labs program. 8. Method transfers and validation activities. 9. Leading the Laboratory Tier 1 / visual management system meetings. 10. Ensuring that the laboratory is operated in a continuous compliant manner & all processes and procedures are followed. 11. Driving Quality System improvements within the QC laboratories. 12. Ownership of Laboratory Systems as assigned. 13. Review and approval (as applicable) ensuring the accuracy, completeness and compliance of: Analytical and associated data generated within the laboratory; procedures (e.g. SOP's, EOP's, Training modules etc.) and Master Analytical Records; compendial changes; analytical change Authorization packages; static data on ZLIMS; Safe Work permits etc. 14. Coach and mentor QC Analysts within their team, supporting their training and development. 15. Support the development of Quality goals and targets as part of the organisation's strategic plan/roadmap. 16. Support development of Quality Operations Budget including resource planning and ensure adherence to Laboratory Budget. 17. Serve as a Quality Culture role model and instill a strong Quality and Compliance Culture within the QC Team. 18. Works with internal and external colleagues and ability to collaborate effectively with others. 19. Drives for Superior Results and Passion to Win with demonstrated record in getting things done. 20. Sets Clear Direction and Aligns Team and Others Around Common Objectives 21. Demonstrates capability to effectively apply knowledge, manage multiple activities simultaneously and balance priorities to deliver objectives. 22. All employees must adhere and comply with cGMP requirements, including Quality Manuals, Policies and Procedures. 23 All employees are expected to model inclusion behaviours. Each team member can influence and bring knowledge to their work teams during their day-to-day interactions. 24. Will contribute to the overall performance of Zoetis and the achievement of the Company's strategic objectives through daily exhibition of Zoetis Core Beliefs and leading by example within the site Quality Team. SYSTEM OWNER / SUBSYSTEM OWNER RESPONSIBILITIES System Owner (SO) System Owners have overall accountability for the site Quality Systems for which they are responsible and in particular for: * Providing strategic & proactive direction with respect to the System (across the site) in terms of content and execution. * Providing support, guidance & coaching to Sub System Owners (SSO). * Ensuring that SSO regularly review sub-systems for their effectiveness, escalating issues where required to site Quality Council (QRC) for action & remediation. * Owning relevant System issues in the site Compliance Plan. * Defining resources as needed & communicating resource needs to Site Lead. * Applying people change control across Sub-Systems within their responsibility. * Ensuring that SSO have proactive continuous improvement plans for their SubSystems. Sub System Owner (SSO) Sub-System Owners have overall accountability for the site Quality Sub-Systems for which they are responsible and in particular for: * Providing strategic & proactive direction with respect to their Sub-System (across the site) in terms of content and execution. * Regularly reviewing their Sub-System & presenting Sub-System review to Quality Council (QRC) as required. Escalating issues where required to the System Owner (SO) and site QRC for action and remediation. * Owning relevant Sub-System issues in the site Compliance Plan. * Defining resources as needed & communicating resource needs to SO. * Developing & implementing proactive continuous improvement plans for their subsystem. * In partnership with the SO, ensuring that there are clearly defined expert(s) for each sub-system, acting as a point of contact during inspections. * Overseeing all documents associated with their sub-system and providing input to the document owners during updates. * Providing comments on new/revised draft policies and guidelines and completing impact assessments where required. ORGANIZATIONAL RELATIONSHIPS This position directly reports to the Site Quality Control Lead. Interact regularly with site Leadership, Global Manufacturing and Technology (GMT), and Operations to ensure site goals and objectives are met. T his position will need to achieve results through collaborating with colleagues directly or indirectly including; * Quality Team - both QA and QC * Manufacturing operations leads and team. * GMT on and offsite * Operational excellence team * Regulatory affairs offsite * GMP inspection /corporate inspection EDUCATION AND EXPERIENCE * Bachelor of Science in Chemistry with 5-10 years of proven quality control and analytical laboratory experience with at least 2 years supervisory experience preferred, and with a demonstrated track record in the management of a modern analytical / microbiology laboratory operating in a GMP environment. * Familiarity with specialized areas such as analytical instrumentation, automated laboratory systems, validation, and current regulatory expectations. * Recognised LSS Qualification (Yellow Belt, Green Belt, Black Belt) preferred. * Experience with water system validation, environmental monitoring standards and process validation. TECHNICAL SKILLS AND COMPETENCIES REQUIRED Ability to provide strong technical and people-based leadership and to work effectively in a team environment with ability to develop and adhere to self-directed standard work. * Excellent written and communication skills, as well as experience with presenting to leadership teams. * In depth knowledge of procedures and work practices relevant to the operation of a Laboratory and associated IT Tools. * Knowledge of regulatory standards (both existing and emerging) relevant to the laboratory. * Experienced in Lean Lab /continuous improvement projects. * Experienced with Problem solving Techniques (e.g., RCI/FMEA) PHYSICAL POSITION REQUIREMENTS This is Rathdrum, Ireland Site based position. * This position requires onsite presence to supervise a 24/7 operational laboratory therefore while occasional remote working may be possible, primarily this is a site-based position Full time Legal statement as below This job advert indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula. Visa status re must be eligible to work and live in Ireland as below Colleague must be legally eligible to live and work in Ireland. Summary of our Benefits In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few. Please note that the benefits outlined are subject to change based on organization decision.