Quality manager jobs in Rocky Mount, NC - 138 jobs

This position for Quality Management Systems (QMS) will ensure compliance with Good Distribution Practices (GDP), 21 CFR regulations, and other applicable standards in a warehouse environment specializing in clinical trial supplies. This role involves implementing, monitoring, and enhancing quality systems to maintain regulatory compliance and ensure operational excellence. Essential Duties and Responsibilities: Manage and oversee the QMS processes, including documentation, control, and implementation of policies and procedures in compliance with GDP, 21 CFR, and industry standards. Conduct routine internal & external audits of warehouse operations to ensure adherence to quality guidelines, regulatory requirements, and standard operating procedures (SOPs). Coordinate and manage deviation investigations, CAPA (Corrective and Preventive Actions), change control processes and Risk Assessments. Ensure Vendor/Customer Verification & Qualification on timely basis also should do audit if required on site of partners site. Accurate documentation check for the each transaction been carried out for the inbound and outbound by the operation team. Ensure accuracy and effective maintenance of the eQMS portal for all quality-related documentation and activities. Reviewing and Authorizing Quality related documents and agreements. Prepare and review quality documentation such as SOPs using eQMS portal, validation protocols, and training records to ensure they meet regulatory and organizational standards. Support regulatory inspections, internal audits, and customer audits by providing necessary documentation and ensuring compliance readiness. Monitor and evaluate the effectiveness of QMS processes through metrics and reporting, identifying areas for improvement. Conduct training sessions for staff on QMS policies, GDP requirements, and regulatory compliance. Collaborate with cross-functional teams, including warehouse operations, logistics, and regulatory affairs, to address quality-related issues and implement improvements. Training the operation team personnel in warehouse. Stay updated on evolving regulatory requirements and incorporate changes into QMS practices. Yearly review on the SOPs if any changes need to be made and upgrade the processes. All documents record should be kept in controlled and secured manner. Work Experience Qualifications: Proven 5+ years of work experience in QMS role within the Pharmaceutical Industry. Result driven orientation having solid customer service attitude with excellent negotiation skills. Previous experience in SAP & MS Office will be an added advantage Must have keen attention to detail and possess proper phone and email etiquette. Ability to stay organized while effectively prioritizing multiple projects at once. High attention to detail when completing projects. Person should be in position to travel for meetings and exhibitions and events. Strong time management skills to complete projects by deadlines. Self-motivated individual who takes ownership of their projects. Administrative skills (MS Office and Google Workspace are required). Maintain excellent verbal, writing, and language skills.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing global quality processes** across the organization. This role ensures that product quality systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement** across all regions and product lines. The Director will lead global initiatives to harmonize and enhance processes related to **product quality complaints, deviations, CAPA, and management reporting** , ensuring timely and effective resolution and robust compliance. **Key Responsibilities** + Global Process Ownership: Lead the design, implementation, and continuous improvement of global quality processes for: + Product Quality Complaints + Corrective and Preventive Actions (CAPA) + Deviations + Management Reporting and Trending + Benchmarking & Best Practices: Evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (e.g., FDA, EMA, PMDA) and align with current GMP standards. + Governance & Standardization: Develop and enforce global standards, SOPs, templates, and tools to ensure consistency across all manufacturing sites and affiliates. + Quality Systems Leadership: Oversee the global deployment and optimization of electronic quality systems (e.g., TrackWise), including configuration, training, and validation. + Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies. + Data-Driven Insights: In collaboration with Quality Operations, lead the development of global quality metrics and dashboards to monitor performance, identify trends, and support decision-making. + Team Leadership: Build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence. **Qualifications** Required **Required Qualifications:** + Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences); advanced degree preferred. + Minimum 12 years of experience in pharmaceutical quality assurance or quality systems, with at least 5 years in a global leadership role. + Deep understanding of GMP regulations and global regulatory requirements (e.g., 21 CFR Parts 210, 211, 820). + Proven experience in managing global quality systems and optimizing complaint, CAPA, and deviation processes. + Strong analytical and problem-solving skills with a data-driven mindset. + Excellent communication, leadership, and stakeholder management skills. + Proficiency in quality management systems (e.g., TrackWise) and Microsoft Office tools. + Ability to travel internationally as needed. Preferred + Basic understanding of artificial intelligence and advanced analytics + Experience supporting risk management programs or frameworks. + Familiarity with quality management systems and digital tools. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Job Description Work in conjunction with diverse clinical teams and utilize community resources to meet the needs of individuals receiving care management services. Provide services in accordance with care management service requirements set by the state and company. Responsible for developing and monitoring Tailored Care Management care plans and Individual Support Plans (ISPs) built from comprehensive assessments to an assigned caseload. Responsibilities Develops positive relationships among and between members, family/guardians, Extenders, clinical and care team members and other community stakeholders to create an environment of compassion and professionalism, driving toward positive health and quality of life outcomes. Responds proactively to alerts from Extenders concerning unmet health-related needs and identified barriers and gaps to reduce adverse health and quality of life indicators. Develops positive relationships with all funding sources that exhibits the willingness to obtain common objectives related to care management. Engages the member/family/guardian to establish rapport and provide required and as needed contact, ensuring service provision is up to date and follow through is completed. In conjunction with the member, selects members for the care team (adjusting as needed). Conducts the Comprehensive Health Assessment on the member, with stakeholder input, to obtain baseline information needed to formulate a care plan. Coordinates, schedules, sets the agenda for and assists the member in chairing care team meetings (times, dates, locations, etc.) and informs all team members. Develops, implements, reassesses, oversees the implementation of and evaluates the Care Plan/ISP for the member to ensure that the members health needs are addressed in a comprehensive, holistic, and preventive manner, with quality as a goal. Manages care transitions and transition plans. Ensures medication monitoring and reconciliation occur. Monitors/implements/supervises delivery of service plans and personal futures plan and training of staff. Documents all information gathered/received electronically in a timely manner. Provides documentation of billable events that align with minimum contact expectations to the Care Management Supervisor. Maintains an accurate, up-to-date electronic information data stream on all interactions, encounters, activities, care team meetings, and communications with the member/family/guardian. Promotes and coordinates comprehensive care among medical, pharmaceutical, psychosocial, social, mental, physical, home health, ancillary providers, and other community agencies, supporting individuals with referrals as needed. Connects members with medical, mental, developmental, psychosocial, housing, transportation, home health, and community support services/systems to achieve a comprehensive, holistic, preventive approach. Empowers the member/family/guardian and other team members with knowledge that aids in implementing the care plan, treatment plan, medication regimen, and appointment keeping. Identifies barriers, gaps, and unmet health-related needs are addresses them proactively, expanding relationships and linkages to aid in meeting member's needs. Supervises up to two FTEs of care management extenders. Provides services that meet national, state, and local healthcare standards at the highest level. Reports issues of concern, general departmental activities and staffing needs to the Care Management Supervisor. Completes all required training and participates in educational sessions to improve overall skills. Attends industry meetings, training, and functions to promote positive relationships with stakeholders. Participates in quality improvement and measurement activities to achieve identified targets and outcomes. Completes other duties as assigned. Qualifications Qualifications: Years of experience as specified below. Two years of experience as a Care Manager, Case Manager, or Care Coordinator preferred. Ability to perform work with a high degree of quality and autonomy. Must meet all agency requirements for pre-employment and those required by the state of NC. Education: A license, provisional license, certificate, registration, or permit issued by the governing board regulating a human service profession, except a registered nurse who is licensed to practice in the State of North Carolina by the North Carolina Board of Nursing who also has four years of full-time accumulated experience with the IDD population; or A Master's degree in a human service field and one year of full-time, post-graduate degree accumulated experience with the IDD population; or A bachelor's degree in a human service field and two years of full-time, post-bachelor's degree accumulated experience with the IDD population; or A bachelor's degree in a field other than human services and four years of full-time, post-bachelor's degree accumulated experience with the IDD population; and For care managers serving members with LTSS needs: two years of prior LTSS and/or HCBS coordination, care delivery monitoring, and care management experience, in addition to the requirements cited above. (This experience may be concurrent with the two years of experience working directly with individuals with I/DD, or a TBI, above.)

Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care. By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare. Datavant is seeking a strategic and hands-on **Director of Quality** to lead product and supplier quality assurance efforts within our **Life Sciences business unit** , which includes the **Datavant Connect** and **Aetion Evidence Platform** . These platforms deliver regulatory-grade real-world data (RWD) solutions through tokenization, data linkage, and privacy-preserving analytics. As Director of Quality, you will own the implementation and evolution of GxP-aligned quality practices that support regulated data services and software. This includes oversight of software validation, privacy compliance, supplier qualification, and audit readiness. You will also lead a team of quality specialists and partner cross-functionally with Product, Engineering, Security, Privacy, and Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards. This role is essential to operationalizing Datavant's **Quality Management System (QMS)** across internal and external stakeholders and enabling continued growth in regulated RWD and evidence generation environments. **What You Will Do** + Lead the development and continuous improvement of Datavant's QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance. + Manage and mentor a team of quality specialists responsible for core functions such as CAPA, internal audits, validation, and supplier monitoring. + Serve as the primary quality liaison to product development teams (Connect and Aetion), providing guidance on SDLC quality controls, validation strategies (GAMP 5, Part 11), and regulatory risk mitigation. + Oversee supplier qualification and re-evaluation processes, including risk-based assessments, audit coordination, and performance monitoring. + Establish and maintain quality metrics (e.g., CAPA closure, audit readiness scores, supplier performance) and drive continuous improvement initiatives. + Support readiness for and participation in customer audits and external assessments (e.g., pharma clients, CROs, regulatory partners). + Partner with Security and Privacy teams to align product and supplier practices with frameworks like HIPAA, GDPR, and FedRAMP. + Lead or support periodic management reviews of the QMS and contribute to strategic quality planning and resource allocation. + Ensure clear documentation and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). + Represent Datavant's quality program in external communications, including client onboarding, RFIs, and quality-related escalations. **What You Need to Succeed** + 8+ years of experience in quality, compliance, or regulatory roles within life sciences, digital health, or regulated software organizations. + Strong working knowledge of relevant regulations and frameworks, including **FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA** , and **GDPR** . + Proven leadership in scaling and operationalizing a **QMS in a SaaS, RWD, or GxP context** . + Experience managing and mentoring cross-functional teams. + Demonstrated success overseeing **validation, supplier oversight, internal audits, and CAPA management** . + Deep understanding of **data governance, privacy, and security** best practices. + Experience interacting with external auditors, customer compliance teams, or regulatory agencies. + Strong communication skills-capable of explaining complex quality topics to product, legal, technical, and customer-facing stakeholders. **What Helps You Stand Out** + Prior experience supporting real-world data (RWD) platforms or evidence generation technologies used in regulatory submissions. + Background working in or with tokenization, health data linkage, or privacy-enhancing technologies. + Experience interfacing directly with pharmaceutical, biotech, or CRO quality teams. + Training or certification in Six Sigma, ISO Auditing, or software validation methodologies. + Familiarity with supplier portals, quality dashboards, or eQMS platforms (e.g., Veeva, MasterControl). + Experience contributing to industry working groups on quality, data integrity, or health data compliance. \#LI-BC1 We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services. The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation. The estimated base salary range (not including variable pay) for this role is: $165,000-$230,000 USD To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion. This job is not eligible for employment sponsorship. Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here (************************************************** . Know Your Rights (*********************************************************************** , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way. Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, (************************************************************** Id=**********48790029&layout Id=**********48795462) by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here (******************************************************************************************************* . Requests for reasonable accommodations will be reviewed on a case-by-case basis. For more information about how we collect and use your data, please review our Privacy Policy (**************************************** .

We Are: Are you ready to step into the heart of digital transformation in one of the world's most critical - and most dynamic - industries? The Chemicals Industry is evolving at lightspeed: demand for sustainability-driven products is on the rise. At the same time, digital platforms, real-time analytics, AI, and SAP-enabled processes are no longer "nice to have" - they are foundational. As part of Accenture's SAP Chemical's Practice, you'll be delivering major SAP engagements (for example, Business Transformation Strategy & Roadmaps, migrations to SAP S/4HANA, process standardization, cloud-enablement) that help clients win in this new environment and guide major Chemical clients through the journey of business-model reinvention, process excellence and enterprise technology enablement You Are: Do you have a passion for storytelling and for originating, selling and delivering SAP-based Supply Chain Transformation projects that make a positive impact in your clients' business? Are you inspired by working with the best companies in their industries? Want a role that provides you with a sense of purpose and satisfaction? Then join Accenture and build a rewarding career improving the way the world works and lives, as you help clients innovate with leading-edge SAP and Accenture Supply Chain solutions and technologies on some of the most innovative projects in the world You will thrive in our highly collaborative, digitally-driven and innovation-led environment while nurturing your talent for thoughtful and game changing solutions in our inclusive culture that values diversity of ideas, experiences and backgrounds. Ultimately, you are a confident manager who spots and stays ahead of the SAP platform, industry and Supply Chain trends and knows how to translate client goals into clear and actionable outcomes that everyone can get behind. You know how to fully utilize the capabilities of various SAP platforms to drive business value, transform end-to-end functions and drive leading practices for your clients in markets all over the globe. The more complex their challenges, the more excited you are about leading the charge to solve them. The Work: Team with clients on their SAP functional transformation programs through your combined SAP application and functional process expertise which includes your ability to: * Engage with client executives on the business challenges/trends and the potential value of SAP solutions (current & future) * Lead customers in defining their SAP journey through the development of business cases & roadmaps including during sales origination, proposal development and client presentations * Architect E2E solutions that leverage SAP technologies, custom apps, & add on partner solutions * Advise, design and deliver solutions based on the latest industry and technology best practices leveraging a SAP solutions and embedded innovation. * Lead small teams - helping them achieve transformational roadmaps - onsite with clients or within Accenture * Become a trusted expert and advisor to your clients, team, and Accenture Leadership by staying current on regulations, trends, and innovations across your area of expertise * Be a thought leader, build assets and best practices and develop the next level of transformation experts Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements Qualification Here's what you need: * Minimum of 5 years of SAP functional and technical experience/expertise in Quality Management and/or Manufacturing. * Minimum 3 years of experience in SAP projects supporting Chemicals clients. (SAP support / managed services experience will not be considered for this requirement) * Minimum 2 end-to-end SAP S/4 implementations, including project planning, estimation and solution architecture for Chemicals clients * Experience managing SAP delivery teams, in a Global Delivery Model, including but not limited to the following responsibilities: driving complex workshops and leading design decisions, as well as leading the design and execution of system build, configuration, testing, cutover, and go-live in the SAP Transportation Management or Quality Management area * Prior experience in a Consulting and/or Advisory role * Bachelor's degree or equivalent (minimum 12 years' work experience). If Associate's Degree, must have equivalent minimum 6-year work experience Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below. We anticipate this job posting will be posted on 01/24/2026 and open for at least 3 days. Accenture offers a market competitive suite of benefits including medical, dental, vision, life, and long-term disability coverage, a 401(k) plan, bonus opportunities, paid holidays, and paid time off. See more information on our benefits here: U.S. Employee Benefits | Accenture Role Location Annual Salary Range California $94,400 to $293,800 Cleveland $87,400 to $235,000 Colorado $94,400 to $253,800 District of Columbia $100,500 to $270,300 Illinois $87,400 to $253,800 Maryland $94,400 to $253,800 Massachusetts $94,400 to $270,300 Minnesota $94,400 to $253,800 New York $87,400 to $293,800 New Jersey $100,500 to $293,800 Washington $100,500 to $270,300 Locations

Join the Leader in Trading Card Manufacturing At Millennium Print Group (MPG), a proud subsidiary of The Pokémon Company International, we're on a mission to be the world's leading manufacturer of trading card games and collectibles. Based in North Carolina's vibrant Research Triangle Park and Piedmont Triad regions, we're at the heart of innovation in this fast-growing industry. Since our founding in 2014, our dedicated team has built a world-class operation known for exceptional quality, customer focus, and market agility. Specializing in trading and collectible cards, we offer a unique range of services that set us apart. Our commitment to excellence has fueled rapid growth - we've nearly tripled in size since 2019 - and we're just getting started. Come be part of a forward-thinking, high-performing team that's shaping the future of collectible printing. At MPG, your work makes an impact. Click here to review our Privacy Notice for applicants. Click here to review our applicant Privacy Notice for SMS Texting and Terms of Service. Director of Quality Join Millennium Print Group as our Director of Quality! We are seeking an experienced Director of Quality to lead enterprise-wide quality strategy, ISO 9001 compliance, and continuous improvement across a fast-paced manufacturing environment. This senior leadership role partners closely with executive leadership to ensure product excellence, regulatory compliance, and customer satisfaction. Location: Raleigh, NC Schedule: Full-Time | Onsite Pay & Benefits: Director-level compensation + bonus eligibility + comprehensive benefits package What You'll Do: Lead company-wide quality strategy, QMS, and ISO 9001 certification efforts Oversee QA and QMS teams responsible for inspections, audits, CAPA, and training Establish quality standards, KPIs, and metrics for defect reduction and process optimization Drive root cause analysis, corrective actions, and continuous improvement initiatives Partner with customers, suppliers, and regulators on quality matters Ensure compliance with ISO, ANSI, OSHA, and customer requirements What You'll Bring: Bachelor's degree in quality, Engineering, or related field 10+ years of quality leadership experience in manufacturing, print, or packaging environments. Proven success leading ISO 9001 systems and audit programs ASQ certifications preferred (CQE, CMQ/OE, CSSBB, CQA) Expertise in Lean, Six Sigma, CAPA, SPC, FMEA, and data-driven quality improvement Strong leadership, communication, and strategic planning skills How You Will Be Successful: Dedicated to Quality and Safety: Setting and Executing Quality Strategy Through the Leadership of High-Performing Quality Teams Challenging the Expected: Lead transformation through continuous improvement and innovation Building Relationships: Collaborate with customers, suppliers, and cross-functional teams Integrity and Respect: Maintain compliance, transparency, and accountability Why Join MPG? Millennium Print Group, a subsidiary of The Pokémon Company International, is the largest trading card printer in the world. We offer competitive compensation, leadership impact, and the opportunity to shape quality standards behind globally recognized brands. Apply today and lead the future of quality at MPG. #MillAll What to Expect MPG offers a leading-edge compensation package which includes the following: A highly competitive compensation "above the industry" commensurate with experience which includes an annual incentive bonus plan 100% Employer-paid medical, dental base plan, vision, life/AD&D, and short-term and long-term disability, while subsidizing premiums for medical, dental, and vision for employee dependents 401(k) Plan with up to a 6% (dollar for dollar) Employer match Health Savings/Flexible Spending Account options Paid time off, including 10 company-paid holidays, plus 1 floating holiday Employee Assistance Program Comprehensive relocation package available for qualified candidates And, much more! Millennium Print Group is an Equal Opportunity Employer The duties and responsibilities described above are essential functions of the job. The following qualifications are representative of the knowledge, skills, and or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Job Description F.A. Wilhelm Construction - Quality Assurance Manager Empowering People to Build What Matters- That is our mission and our legacy. Our nearly 100 years of building communities in which we work and play, started with one man and one dream. Today, we are a company that puts People First by providing Meaningful Partnerships, insisting on making a Positive Community Impact, with Safety Always, all with a Learn-Do-Share mentality. F.A. Wilhelm Construction is an industry leader with the culture of doing the right things for our employees, partners, clients, and community. We have an excellent reputation in the construction industry and have enjoyed steady growth and strong financial performances for many years. Wilhelm's construction professionals turn the conceptual, and sometimes seemingly impossible, into fully completed, innovative spaces where life happens. We are looking for the right person to join our team as a Quality Assurance Manager. Is that you? If so, we want to talk to you! Responsibilities As a quality assurance manager, your key responsibility will be to help create, plan, manage, and enforce Wilhelm's Quality Assurance Program for the assigned project(s) by preventing "Q" issues, making observations, identifying potential issues, then creating/implementing a specific plan in order to eliminate any errors that could result in a quality deficient product. Develops and/or assists in development of a QA/QC program which meets each project's and/or owner's contractual requirements. Ensure that all subcontractors and personnel working on the project understand the project and manufacture's requirements. Manage self-perform and subcontracted work through Project Specific Quality Plans including Inspection and Test Plans, Check lists, proper training, and mock-ups, etc. Perform onsite field observation of in-progress and installed work including all civil, structural, enclosure, interiors, MEP systems, etc. Record observations from job site inspections, complete inspection reports, recommend and implement corrective action based on policies, guidelines, and procedures Key Attributes Comfortable at the table with all levels of leadership Collaborator Integrity Organized and systematic Proactive problem solver with outstanding interpersonal skills Commitment to excellence What it takes Bachelor's degree in Engineering, Construction Management, Construction Science, or other related field with a minimum of 3 years General Construction In lieu of a degree, minimum of 5+ years General Construction work experience OSHA 30-hour certification preferred, but not required Microsoft Applications - intermediate to advanced knowledge (Windows, Word, Excel, Outlook) Procore or other Construction Quality Software Primavera P6 Scheduling Software Viewpoint - intermediate knowledge Bluebeam - intermediate knowledge F.A. Wilhelm offers a unique opportunity for the right person to experience a variety of project work. Working at F.A Wilhelm, you can expect: A competitive compensation package. A comprehensive benefits package to include medical, dental, vision, and 401K match. Basic life insurance and short-term & long-term disability insurance is paid for by F.A Wilhelm. Discretionary yearly bonus program. A generous PTO bank. Wilhelm University access for training/development. Powered by ExactHire:187446

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Quality Control (QC) Manager serves as a Quality Control technical resource to the plant. She/he is the primary point of contact for the testing of all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and corporate objectives. The Quality Control Manager is responsible for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC laboratories, supervising testing processes, and ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations (FDA, EMA, ICH). This individual will provide overall QC leadership regarding cGMP compliance concerns and improvements, as well as manage budget line items, overtime, efficiency improvements, and staffing. Job Description ESSENTIAL FUNCTIONS: Develop and implement QC policies, SOPs, and testing protocols in compliance with GMP and regulatory guidelines. Oversee analysis of raw materials, in-process samples, and finished products to ensure they meet specifications. Ensure adherence to FDA, EMA, and other regulatory standards, including PIC/S GMP requirements. Maintain accurate records of all QC activities, including test results, deviations, and corrective actions. Manage and train QC staff, assign tasks, and monitor performance to maintain high standards of quality. Identify quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA). Prepare for and participate in internal and external audits, including regulatory inspections. Oversee calibration, validation, and maintenance of laboratory instruments. Provides subject matter assistance for LIMS, methods, testing, and validation. Manages QC testing group to achieve compliant testing in a timely manner. Manages Lab investigations and OOSs including remediation of potential compliance concerns. Provides overall leadership to QC group regarding cGMP compliance improvement and enhancement. Studies and improves various Quality processes providing increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation. Drives Quality consistency through reviewing/revising various analytical methods/SOPs to ensure adequacy with special emphasis on actual utility of methods under normal QC conditions. Works with plant Managers/Supervisors and Quality technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations. Acts as a liaison between the lab and manufacturing/ R&D for investigations and to implement special projects, assist with validations, method transfers, or technology upgrades. Works with groups to ensure compliance to EHS and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in the laboratory. Ensures key turnaround timelines for customer service and compliance requirements are achieved. Performs as a subject matter expert during customer and regulatory audits. Work closely with Production, R&D, and Quality Assurance teams to ensure product quality throughout the lifecycle. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Develops and coaches to build talent. Participate in a 5S Workplace System to ensure good housekeeping and organization. Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy. Effectively trains others in a positive manner. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: B.S. /B.A. in Physical Science required. Master's Degree preferred. Experience: 10 - 12 years related experience preferred; at least five years of experience in a supervisory role; strong knowledge of current pharmaceutical cGMP requirements Preferred Skills/Qualifications: Other Skills/Competencies: Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories Experience with testing API or Pharma products Experience leading a group of up to 20 people with 24/7 shift operations Excellent written and verbal communication and leadership skills Ability to work in and promote a team environment Working knowledge of Six Sigma and/or Lean manufacturing tools Sense of urgency. Action oriented/drives for results Excellent communication and interpersonal skills Team orientation/strong team player Ability to coach, mentor and teach Excellent decision making, problem solving and analytical skills Strong managerial courage Ability to influence change at all levels of the organization Detail-oriented with the ability to work under tight deadlines Excellent conflict management skills Builds positive relationships with others Excellent time management and prioritization skills Excellent technical writing skills LIMS experience preferred Knows the difference between managing and leading and when to apply each Command Skills, Action Oriented, Conflict Management, Customer Focus, Problem Solving, Priority Setting, Written Communication, RELATIONSHIP WITH OTHERS/ SCOPE: Reports to Site Quality Director Work is performed without appreciable direction Develops strategic objectives for group managed Exercises considerable latitude in determining technical objectives of assignment Completed work is reviewed for desired results from a relatively long-term perspective Bias toward change, management of change, and achievement of results Contact with FDA as subject matter expert during site inspections and customers during frequent customer audits Regular contacts include Quality Assurance, Materials Management, Logistics, Commercial, R&D, Site Production Leaders and EH&S. This position has several direct reports WORKING CONDITIONS: 60% normal office and meeting room conditions. 40% Laboratory and Plant environment including exposure to raw materials and finished products. Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines. Some off shift and weekend work can be expected; travel requirements are minimal DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Wilson, North Carolina, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are currently seeking a Quality Control Lab Services Manager, to join the Quality Team for the new Johnson & Johnson Large Molecule Drug Substance Manufacturing facility in Wilson, North Carolina. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. The QC Lab Services Manager is responsible for leading the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others. Key Responsibilities: · Responsible for the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others. · Perform budget support as the point of contact for activities related to CAPEX, CIP tracking /reporting and spend tracking and reporting. · Support and facilitate the performance management and laboratory planning processes through the laboratory scheduling/planning tools, reporting scorecard metrics and monitoring laboratory indicators. · Lead QC project activities to introduce new products, technologies and computer base applications to improve laboratory efficiency and promote culture of Innovation. · Connect with the QC Global organization being the point of contact for the different center of excellence for equipment and information technologies. · Manage the development of a long-term vision and strategy for these quality systems in close cooperation with the site leadership and translating these strategies into compliant programs and processes in line with regulations and business expectations. · Responsible for the site's Management Review program including the Quality metrics program, to ensure and proactively enhance compliance and business performance of the site. · Responsible for hiring, managing, leading, and motivating the Quality Systems team; inclusive of mentoring, training, and development of department employees. · Manage the resolution of unexpected complex compliance or quality system issues as they arise · Keep abreast of regulatory changes and industry best practices related to laboratory services and ensure timely implementation of necessary updates. · Manage relationships with external regulatory agencies and auditors, supporting inspections and audits, as required. · Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset. · Support the development of the Quality department budget in line with routine business planning cycles. · 10% travel expected (domestic or international). Qualifications Required: · Bachelor's degree in a scientific or engineering discipline. · Minimum of 6 years of experience working within the biological and/or pharmaceutical industry. · Experience in a Quality leadership role. · Analytical equipment qualification experience. · Experience working with Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management, systems and/or CSV support coordination. · Deep understanding and experience in application of global regulatory (FDA, EMA, ICH, etc.) guidelines in a biological or pharmaceutical manufacturing environment. · Experience interacting with health authorities and taking a leading role in regulatory inspections and audits. Preferred: · Experience in supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.). · Certification in quality management systems (e.g., Certified Quality Manager, Certified Quality Auditor). · An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements. · Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels. · Strong analytical and problem-solving skills, with a track record in leading investigations and implementing effective CAPAs. · Proven ability to manage multiple priorities and work independently with minimal supervision. · Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements. · Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment. · Ability to build and nurture strong and positive relationships. · The ability to work in a team environment and interact with all levels of the organization. · Results-driven leader who commits to stretch goals and delivers results. Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs. If you are passionate about quality management in the pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a QC Lab Services Manager. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Wilson, North Carolina, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are currently seeking a Quality Control Lab Services Manager, to join the Quality Team for the new Johnson & Johnson Large Molecule Drug Substance Manufacturing facility in Wilson, North Carolina. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. The QC Lab Services Manager is responsible for leading the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others. Key Responsibilities: · Responsible for the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others. · Perform budget support as the point of contact for activities related to CAPEX, CIP tracking /reporting and spend tracking and reporting. · Support and facilitate the performance management and laboratory planning processes through the laboratory scheduling/planning tools, reporting scorecard metrics and monitoring laboratory indicators. · Lead QC project activities to introduce new products, technologies and computer base applications to improve laboratory efficiency and promote culture of Innovation. · Connect with the QC Global organization being the point of contact for the different center of excellence for equipment and information technologies. · Manage the development of a long-term vision and strategy for these quality systems in close cooperation with the site leadership and translating these strategies into compliant programs and processes in line with regulations and business expectations. · Responsible for the site's Management Review program including the Quality metrics program, to ensure and proactively enhance compliance and business performance of the site. · Responsible for hiring, managing, leading, and motivating the Quality Systems team; inclusive of mentoring, training, and development of department employees. · Manage the resolution of unexpected complex compliance or quality system issues as they arise · Keep abreast of regulatory changes and industry best practices related to laboratory services and ensure timely implementation of necessary updates. · Manage relationships with external regulatory agencies and auditors, supporting inspections and audits, as required. · Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset. · Support the development of the Quality department budget in line with routine business planning cycles. · 10% travel expected (domestic or international). Qualifications Required: · Bachelor's degree in a scientific or engineering discipline. · Minimum of 6 years of experience working within the biological and/or pharmaceutical industry. · Experience in a Quality leadership role. · Analytical equipment qualification experience. · Experience working with Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management, systems and/or CSV support coordination. · Deep understanding and experience in application of global regulatory (FDA, EMA, ICH, etc.) guidelines in a biological or pharmaceutical manufacturing environment. · Experience interacting with health authorities and taking a leading role in regulatory inspections and audits. Preferred: · Experience in supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.). · Certification in quality management systems (e.g., Certified Quality Manager, Certified Quality Auditor). · An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements. · Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels. · Strong analytical and problem-solving skills, with a track record in leading investigations and implementing effective CAPAs. · Proven ability to manage multiple priorities and work independently with minimal supervision. · Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements. · Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment. · Ability to build and nurture strong and positive relationships. · The ability to work in a team environment and interact with all levels of the organization. · Results-driven leader who commits to stretch goals and delivers results. Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs. If you are passionate about quality management in the pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a QC Lab Services Manager. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills:

F.A. Wilhelm Construction - Quality Assurance Manager Empowering People to Build What Matters- That is our mission and our legacy. Our nearly 100 years of building communities in which we work and play, started with one man and one dream. Today, we are a company that puts People First by providing Meaningful Partnerships, insisting on making a Positive Community Impact, with Safety Always, all with a Learn-Do-Share mentality. F.A. Wilhelm Construction is an industry leader with the culture of doing the right things for our employees, partners, clients, and community. We have an excellent reputation in the construction industry and have enjoyed steady growth and strong financial performances for many years. Wilhelm's construction professionals turn the conceptual, and sometimes seemingly impossible, into fully completed, innovative spaces where life happens. We are looking for the right person to join our team as a Quality Assurance Manager. Is that you? If so, we want to talk to you! Responsibilities As a quality assurance manager, your key responsibility will be to help create, plan, manage, and enforce Wilhelm's Quality Assurance Program for the assigned project(s) by preventing "Q" issues, making observations, identifying potential issues, then creating/implementing a specific plan in order to eliminate any errors that could result in a quality deficient product. * Develops and/or assists in development of a QA/QC program which meets each project's and/or owner's contractual requirements. * Ensure that all subcontractors and personnel working on the project understand the project and manufacture's requirements. * Manage self-perform and subcontracted work through Project Specific Quality Plans including Inspection and Test Plans, Check lists, proper training, and mock-ups, etc. * Perform onsite field observation of in-progress and installed work including all civil, structural, enclosure, interiors, MEP systems, etc. * Record observations from job site inspections, complete inspection reports, recommend and implement corrective action based on policies, guidelines, and procedures Key Attributes * Comfortable at the table with all levels of leadership * Collaborator * Integrity * Organized and systematic * Proactive problem solver with outstanding interpersonal skills * Commitment to excellence What it takes * Bachelor's degree in Engineering, Construction Management, Construction Science, or other related field with a minimum of 3 years General Construction * In lieu of a degree, minimum of 5+ years General Construction work experience * OSHA 30-hour certification preferred, but not required * Microsoft Applications - intermediate to advanced knowledge (Windows, Word, Excel, Outlook) * Procore or other Construction Quality Software * Primavera P6 Scheduling Software * Viewpoint - intermediate knowledge * Bluebeam - intermediate knowledge F.A. Wilhelm offers a unique opportunity for the right person to experience a variety of project work. Working at F.A Wilhelm, you can expect: * A competitive compensation package. * A comprehensive benefits package to include medical, dental, vision, and 401K match. Basic life insurance and short-term & long-term disability insurance is paid for by F.A Wilhelm. * Discretionary yearly bonus program. * A generous PTO bank. * Wilhelm University access for training/development.

Country: United States of America Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: This job requires a U.S. Person. A U.S. Person is a lawful permanent resident as defined in 8 U.S.C. 1101(a)(20) or who is a protected individual as defined by 8 U.S.C. 1324b(a)(3). U.S. citizens, U.S. nationals, U.S. permanent residents, or individuals granted refugee or asylee status in the U.S. are considered U.S. persons. For a complete definition of “U.S. Person” go here. ********************************************************************************************** Security Clearance: None/Not Required The Fire Protection business unit at Collins Aerospace is seeking a Customer Quality Program Manager (CQM). The CQM acts as the primary customer point of contact for quality and is focused on improving customer satisfaction through quality improvement initiatives. The CQM serves as the customer's voice throughout the organization, working alongside program management to lead a cross functional team in the resolution of known issues and drive preventative actions to reduce quality escapes. This position is in a multi-disciplinary team environment and will require one who thrives on tackling challenges. The position relies on the use of problem-solving skills in a hands-on work environment to address problems and implement appropriate solutions. A successful candidate will have some technical knowledge of manufacturing processes and experience with requirements compliance. Familiarity with purchase/sales order logistics is also desired. Heavy customer interaction will be required in this role to develop and maintain a collaborative rapport. What You Will Do: Accountable for root cause corrective action investigations for nonconformance escapes with a cross functional team including members from product quality, manufacturing engineering, design engineering, operations, etc. Performs escape management procedures for disclosure of nonconforming hardware Leads customer audits/assessments as required Manages customer satisfaction metrics and develops plans to recover and maintain goals Review customer quality requirements to ensure compliance with requirements, objectives, and/or contracts Identifies and manages risk in product development primarily utilizing and driving PPAP core elements (e.g. PFMEA, MSA, Process Flow and Control Plans, etc.) Qualifications You Must Have: Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and minimum 8 years prior relevant experience or an Advanced Degree in a related field In-depth knowledge of Quality Management System(s) and Root Cause Analysis tools. Experienced and comfortable with customer-facing responsibilities Qualifications You Must Have: 5+ years in Aerospace with solid knowledge of Quality Assurance in production / manufacturing and new product development. FAA, EASA and other regulatory authority knowledge with PMR / MRB, Corrective action methodology experience is desired. Certified in the appropriate ASQ Body of Knowledge (CQE, CQA, CRE, CPA) What We Offer: Some of our competitive benefits package includes: Medical, dental, and vision insurance Three weeks of vacation for newly hired employees Generous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy option Tuition reimbursement program Student Loan Repayment Program Life insurance and disability coverage Optional coverages you can buy pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection Birth, adoption, parental leave benefits Ovia Health, fertility, and family planning Adoption Assistance Autism Benefit Employee Assistance Plan, including up to 10 free counseling sessions Healthy You Incentives, wellness rewards program Doctor on Demand, virtual doctor visits Bright Horizons, child and elder care services Teladoc Medical Experts, second opinion program This position may be eligible for relocation And more! Learn More and Apply Now! Collins Aerospace, a RTX company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market. Our Avionics team advances flight deck solutions, airborne communications, vision systems, sensors and fire protection for commercial and military customers around the world. That means we're helping people reach their destination safely and keeping pilots, passengers, flight crews, airlines, airports and military personnel connected and informed. And we're providing industry-leading fire protection and safety systems that our customers can count on when it matters most. Are you ready to learn from the most knowledgeable experts in the industry, develop the technologies of tomorrow and reach new heights in your career? Join our Avionics team today. WE ARE REDEFINING AEROSPACE. * Please consider the following role type definitions as you apply for this role. Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products. Regardless of your role type, collaboration and innovation are critical to our business and all employees will have access to digital tools so they can work with colleagues around the world - and access to Collins sites when their work requires in-person meetings. At Collins, the paths we pave together lead to limitless possibility. And the bonds we form - with our customers and with each other -- propel us all higher, again and again. Apply now and be part of the team that's redefining aerospace, every day. As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote. The salary range for this role is 107,500 USD - 204,500 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act. Privacy Policy and Terms: Click on this link to read the Policy and Terms

**Country:** United States of America ** Onsite **U.S. Citizen, U.S. Person, or Immigration Status Requirements:** This job requires a U.S. Person. A U.S. Person is a lawful permanent resident as defined in 8 U.S.C. 1101(a)(20) or who is a protected individual as defined by 8 U.S.C. 1324b(a)(3). U.S. citizens, U.S. nationals, U.S. permanent residents, or individuals granted refugee or asylee status in the U.S. are considered U.S. persons. For a complete definition of "U.S. Person" go here. ********************************************************************************************** **Security Clearance:** None/Not Required The Fire Protection business unit at Collins Aerospace is seeking a Customer Quality Program Manager (CQM). The CQM acts as the primary customer point of contact for quality and is focused on improving customer satisfaction through quality improvement initiatives. The CQM serves as the customer's voice throughout the organization, working alongside program management to lead a cross functional team in the resolution of known issues and drive preventative actions to reduce quality escapes. This position is in a multi-disciplinary team environment and will require one who thrives on tackling challenges. The position relies on the use of problem-solving skills in a hands-on work environment to address problems and implement appropriate solutions. A successful candidate will have some technical knowledge of manufacturing processes and experience with requirements compliance. Familiarity with purchase/sales order logistics is also desired. Heavy customer interaction will be required in this role to develop and maintain a collaborative rapport. **What You Will Do:** + Accountable for root cause corrective action investigations for nonconformance escapes with a cross functional team including members from product quality, manufacturing engineering, design engineering, operations, etc. + Performs escape management procedures for disclosure of nonconforming hardware + Leads customer audits/assessments as required + Manages customer satisfaction metrics and develops plans to recover and maintain goals + Review customer quality requirements to ensure compliance with requirements, objectives, and/or contracts + Identifies and manages risk in product development primarily utilizing and driving PPAP core elements (e.g. PFMEA, MSA, Process Flow and Control Plans, etc.) **Qualifications You Must Have:** + Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and minimum 8 years prior relevant experience **or** an Advanced Degree in a related field + In-depth knowledge of Quality Management System(s) and Root Cause Analysis tools. + Experienced and comfortable with customer-facing responsibilities **Qualifications You Must Have:** + 5+ years in Aerospace with solid knowledge of Quality Assurance in production / manufacturing and new product development. + FAA, EASA and other regulatory authority knowledge with PMR / MRB, Corrective action methodology experience is desired. + Certified in the appropriate ASQ Body of Knowledge (CQE, CQA, CRE, CPA) **What We Offer:** _Some of our competitive benefits package includes: _ + Medical, dental, and vision insurance + Three weeks of vacation for newly hired employees + Generous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy option + Tuition reimbursement program + Student Loan Repayment Program + Life insurance and disability coverage + Optional coverages you can buy pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection + Birth, adoption, parental leave benefits + Ovia Health, fertility, and family planning + Adoption Assistance + Autism Benefit + Employee Assistance Plan, including up to 10 free counseling sessions + Healthy You Incentives, wellness rewards program + Doctor on Demand, virtual doctor visits + Bright Horizons, child and elder care services + Teladoc Medical Experts, second opinion program + This position may be eligible for relocation + And more! **Learn More and Apply Now!** Collins Aerospace, a RTX company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market. Our **Avionics** team advances flight deck solutions, airborne communications, vision systems, sensors and fire protection for commercial and military customers around the world. That means we're helping people reach their destination safely and keeping pilots, passengers, flight crews, airlines, airports and military personnel connected and informed. And we're providing industry-leading fire protection and safety systems that our customers can count on when it matters most. Are you ready to learn from the most knowledgeable experts in the industry, develop the technologies of tomorrow and reach new heights in your career? Join our Avionics team today. **WE ARE REDEFINING AEROSPACE.** * Please consider the following role type definitions as you apply for this role. **Onsite:** Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products. _Regardless of your role type, collaboration and innovation are critical to our business and all employees will have access to digital tools so they can work with colleagues around the world - and access to Collins sites when their work requires in-person meetings._ At Collins, the paths we pave together lead to limitless possibility. And the bonds we form - with our customers and with each other -- propel us all higher, again and again. Apply now and be part of the team that's redefining aerospace, every day. **_As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote._** The salary range for this role is 107,500 USD - 204,500 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills. Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement. Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance. This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply. RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. _RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act._ **Privacy Policy and Terms:** Click on this link (******************************************************** to read the Policy and Terms Raytheon Technologies is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.

Responsive recruiter Benefits: Competitive salary Dental insurance Free uniforms Health insurance Paid time off Vision insurance 401(k) matching Bonus based on performance Company car Position: Quality Control Manager Description: Cooper Tacia General Contracting is seeking an experienced and highly motivated Quality Control (QC) Manager to oversee quality management for our Federal Projects, in compliance with the U.S. Army Corps of Engineers (USACE) standards and specifications. This role is critical to ensure that all construction activities meet contract requirements, safety protocols, and quality benchmarks mandated by USACE and Cooper Tacia's internal QA/QC systems. The ideal candidate will have a proven track record in federal construction projects and a strong understanding of USACE's Three-Phase QC System. Responsibilities: · Implement and manage the project-specific QA/QC Plan in full compliance with USACE EM 385-1-1 and the Three-Phase Quality Control System, ensuring strict adherence to contract documents and quality standards. · Act as the primary liaison with USACE, overseeing all correspondence, inspections, and quality documentation, including Daily QC Reports, submittals, RFIs, and Definable Features of Work (DFOW) tracking. · Plan, coordinate, and lead Preparatory, Initial, and Follow-Up QC meetings with subcontractors and field personnel to ensure readiness, approved materials, and clear quality expectations. · Conduct and document field inspections and third-party testing, analyze results, and manage corrective actions for non-compliant work, including verification of all reworks prior to progression. · Collaborate with the project team to proactively resolve design conflicts and material compliance issues, ensuring quality and constructability align with project goals and schedules. · Maintain and update all QA/QC records, including punch lists, non-conformance reports (NCRs), and corrective action logs, supporting smooth project turnover and closeout documentation. · Promote a culture of quality by integrating Lean construction methods, enforcing QA/QC and safety alignment, and driving continuous improvement in field and office operations. Requirements:· Minimum of 2-5 years of overall construction experience, in a dedicated QA/QC role preferably on U.S. Army Corps of Engineers (USACE) or other federal projects.· Current USACE Construction Quality Management (CQM) for Contractors certification (must be maintained throughout project duration). · Strong knowledge of EM 385-1-1, Unified Facilities Guide Specifications (UFGS), and the Three-Phase QC System, with proven ability to implement them in the field. · Proficiency in construction management software, including Procore, Microsoft Office, and familiarity with RMS/QCS systems preferred. · Exceptional organizational, documentation, and communication skills, with the ability to manage multiple QA/QC workflows and coordinate across teams. · Must be a U.S. citizen and able to pass a background check for base access; valid driver's license required. Employment Type: Full Time Salary: $85,000-$120,000 Benefits: · 100% Employer Paid Health, Vision & Dental Insurance for employee.· PTO/ Paid Holidays· 401K W/ 3% Match · Continued Education as needed.· Company Vehicle with Fuel Card.· Annual Performance bonus Application Process: All interested individuals must submit a resume and three references. Email to: ******************************* We are an equal opportunity and drug-free workplace. Pre-employment drug screening required. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of responsibilities, duties and skills required. Personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Compensation: $85,000.00 - $120,000.00 per year We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Join the Cooper Tacia General Contracting Company Team At Cooper Tacia General Contracting Company, we believe in building excellence from the ground up. Our story began in 1996 with John Cooper and Chris Tacia, two high school students who transformed a firewood business into a leading construction company. Today, we deliver top-quality projects across the southeast United States. Why Work with Us? We value innovation, collaboration, and professional growth. Here's why you should consider a career with Cooper Tacia: Diverse Projects: Work on a wide range of projects, including manufacturing facilities, office buildings, government and education facilities, restaurant and retail spaces, apartment complexes, and water treatment plant upgrades. Career Development: We are committed to your growth, offering opportunities for continuous learning and advancement. Supportive Environment: Join a team of dedicated professionals who are passionate about what they do. Excellence in Every Project: Contribute to high-quality projects that make a real impact. Competitive Benefits and Compensation: Enjoy a comprehensive benefits package, including health insurance, retirement plans, paid time off, and competitive salaries. We pay 100% of employee benefits for the employee only, offer a 401(k) with a 3% match, 10 days of PTO, and paid holidays. Explore Career OpportunitiesWe are always on the lookout for talented individuals to join our team. Whether you're an experienced professional or just starting your career, we have opportunities that can help you grow and succeed.

The Quality Systems Specialist is responsible for supporting the Quality Management System (QMS), including GxP document management and training programs. This role ensures compliance with regulatory standards, maintains the integrity of documentation systems, and collaborates with cross-functional teams to support document and training needs. Essential Duties GxP Document Management Collaborate cross-functionally to generate workflow status reports and support document owners with new document creation and revisions. Review procedural documents for compliance with formatting, metadata, and applicable standards. Initiate periodic review workflows. Serve as workflow owner as needed. Assist document owners in ensuring proper GxP records management. Create document reports to support business processes, including periodic review and stagnant draft reports. Generate document owner, workflow owner, and task owner reports to support offboarding activities and transfer ownership as appropriate. Training Program Support Generate training reports and distribute upcoming and overdue training notifications. Initiate training assessment forms for managers of new personnel. Create learner roles, training requirements, and curricula within the training management system. Quality Management System Support Schedule and facilitate initial and status meetings. Route forms for electronic signature and maintain tracking logs. Upload completed forms into the document management system. Audits and Inspections Prepare for and participate in internal and external audits related to document control and quality systems. Skills & Education Requirements Bachelor's degree in Life Sciences or a related field, or an Associate degree with relevant work experience. Minimum of 5 years of document control experience. Proficiency with electronic document management systems (e.g., Veeva QualityDocs). Experience supporting gene and cell therapy products. Prior experience in a startup or fast-paced environment. Demonstrated integrity, accountability, and strong teamwork skills.

The Director, Quality & Compliance Training, is a senior leader within the Learning Center of Excellence under Global Quality. This role is responsible for developing and executing global training strategies for various functions (e.g., Commercial, Finance, HR, Legal, and other General & Administrative areas). The position ensures that learning programs drive business performance, compliance with corporate standards, and foster a culture of continuous development across the organization. **Key Responsibilities:** **Strategic Leadership & Governance** + Define and lead the global training strategy aligned with corporate objectives and quality principles. + Establish governance frameworks for training compliance and operational excellence, including policies and SOPs. + Serve as a key advisor to senior leadership on learning trends, capability-building strategies, and risk mitigation. **Program Development & Delivery** + Design and oversee training programs for Commercial and G&A functions, ensuring relevance and scalability. + Implement innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches. + Ensure training content aligns with corporate standards and supports organizational priorities. **Stakeholder Engagement & Collaboration** + Partner with functional leaders, HR, and Quality to identify learning needs and align initiatives with business goals. + Act as a trusted advisor to senior leadership on training effectiveness and workforce capability development. **Continuous Improvement & Analytics** + Define KPIs and leverage data analytics to measure training impact and drive enhancements. + Stay current with industry best practices, emerging technologies, and evolving business needs to continuously improve learning programs. **Operational Oversight** + Collaborate with training operations teams to ensure efficient delivery and compliance tracking. + Oversee vendor relationships for training services and technology solutions **Qualifications:** + Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred. + 10+ years in pharmaceutical or life sciences industry with significant experience designing and implementing global training programs. + Proven track record in designing and implementing global training programs and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.). + Proven ability to design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies. + Excellent communication, collaboration, and stakeholder engagement skills. **Preferred Attributes:** + Strategic thinker with a passion for scientific learning and development. + Agile and adaptable in a fast-paced, matrixed environment. + Strong project management and organizational skills. + Committed to fostering innovation, compliance, and continuous improvement through learning. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Job DescriptionBenefits: Competitive salary Dental insurance Free uniforms Health insurance Paid time off Vision insurance 401(k) matching Bonus based on performance Company car Position: Quality Control Manager Description: Cooper Tacia General Contracting is seeking an experienced and highly motivated Quality Control (QC) Manager to oversee quality management for our Federal Projects, in compliance with the U.S. Army Corps of Engineers (USACE) standards and specifications. This role is critical to ensure that all construction activities meet contract requirements, safety protocols, and quality benchmarks mandated by USACE and Cooper Tacias internal QA/QC systems. The ideal candidate will have a proven track record in federal construction projects and a strong understanding of USACEs Three-Phase QC System. Responsibilities: Implement and manage the project-specific QA/QC Plan in full compliance with USACE EM 385-1-1 and the Three-Phase Quality Control System, ensuring strict adherence to contract documents and quality standards. Act as the primary liaison with USACE, overseeing all correspondence, inspections, and quality documentation, including Daily QC Reports, submittals, RFIs, and Definable Features of Work (DFOW) tracking. Plan, coordinate, and lead Preparatory, Initial, and Follow-Up QC meetings with subcontractors and field personnel to ensure readiness, approved materials, and clear quality expectations. Conduct and document field inspections and third-party testing, analyze results, and manage corrective actions for non-compliant work, including verification of all reworks prior to progression. Collaborate with the project team to proactively resolve design conflicts and material compliance issues, ensuring quality and constructability align with project goals and schedules. Maintain and update all QA/QC records, including punch lists, non-conformance reports (NCRs), and corrective action logs, supporting smooth project turnover and closeout documentation. Promote a culture of quality by integrating Lean construction methods, enforcing QA/QC and safety alignment, and driving continuous improvement in field and office operations. Requirements: Minimum of 2-5 years of overall construction experience, in a dedicated QA/QC role preferably on U.S. Army Corps of Engineers (USACE) or other federal projects. Current USACE Construction Quality Management (CQM) for Contractors certification (must be maintained throughout project duration). Strong knowledge of EM 385-1-1, Unified Facilities Guide Specifications (UFGS), and the Three-Phase QC System, with proven ability to implement them in the field. Proficiency in construction management software, including Procore, Microsoft Office, and familiarity with RMS/QCS systems preferred. Exceptional organizational, documentation, and communication skills, with the ability to manage multiple QA/QC workflows and coordinate across teams. Must be a U.S. citizen and able to pass a background check for base access; valid drivers license required. Employment Type: Full Time Salary: $85,000-$120,000 Benefits: 100% Employer Paid Health, Vision & Dental Insurance for employee. PTO/ Paid Holidays 401K W/ 3% Match Continued Education as needed. Company Vehicle with Fuel Card. Annual Performance bonus Application Process: All interested individuals must submit a resume and three references. Email to: ******************************* We are an equal opportunity and drug-free workplace. Pre-employment drug screening required. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of responsibilities, duties and skills required. Personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Our Company ResCare Community Living Work in conjunction with diverse clinical teams and utilize community resources to meet the needs of individuals receiving care management services. Provide services in accordance with care management service requirements set by the state and company. Responsible for developing and monitoring Tailored Care Management care plans and Individual Support Plans (ISPs) built from comprehensive assessments to an assigned caseload. Responsibilities Develops positive relationships among and between members, family/guardians, Extenders, clinical and care team members and other community stakeholders to create an environment of compassion and professionalism, driving toward positive health and quality of life outcomes. Responds proactively to alerts from Extenders concerning unmet health-related needs and identified barriers and gaps to reduce adverse health and quality of life indicators. Develops positive relationships with all funding sources that exhibits the willingness to obtain common objectives related to care management. Engages the member/family/guardian to establish rapport and provide required and as needed contact, ensuring service provision is up to date and follow through is completed. In conjunction with the member, selects members for the care team (adjusting as needed). Conducts the Comprehensive Health Assessment on the member, with stakeholder input, to obtain baseline information needed to formulate a care plan. Coordinates, schedules, sets the agenda for and assists the member in chairing care team meetings (times, dates, locations, etc.) and informs all team members. Develops, implements, reassesses, oversees the implementation of and evaluates the Care Plan/ISP for the member to ensure that the members health needs are addressed in a comprehensive, holistic, and preventive manner, with quality as a goal. Manages care transitions and transition plans. Ensures medication monitoring and reconciliation occur. Monitors/implements/supervises delivery of service plans and personal futures plan and training of staff. Documents all information gathered/received electronically in a timely manner. Provides documentation of billable events that align with minimum contact expectations to the Care Management Supervisor. Maintains an accurate, up-to-date electronic information data stream on all interactions, encounters, activities, care team meetings, and communications with the member/family/guardian. Promotes and coordinates comprehensive care among medical, pharmaceutical, psychosocial, social, mental, physical, home health, ancillary providers, and other community agencies, supporting individuals with referrals as needed. Connects members with medical, mental, developmental, psychosocial, housing, transportation, home health, and community support services/systems to achieve a comprehensive, holistic, preventive approach. Empowers the member/family/guardian and other team members with knowledge that aids in implementing the care plan, treatment plan, medication regimen, and appointment keeping. Identifies barriers, gaps, and unmet health-related needs are addresses them proactively, expanding relationships and linkages to aid in meeting member's needs. Supervises up to two FTEs of care management extenders. Provides services that meet national, state, and local healthcare standards at the highest level. Reports issues of concern, general departmental activities and staffing needs to the Care Management Supervisor. Completes all required training and participates in educational sessions to improve overall skills. Attends industry meetings, training, and functions to promote positive relationships with stakeholders. Participates in quality improvement and measurement activities to achieve identified targets and outcomes. Completes other duties as assigned. Qualifications Qualifications: Years of experience as specified below. Two years of experience as a Care Manager, Case Manager, or Care Coordinator preferred. Ability to perform work with a high degree of quality and autonomy. Must meet all agency requirements for pre-employment and those required by the state of NC. Education: A license, provisional license, certificate, registration, or permit issued by the governing board regulating a human service profession, except a registered nurse who is licensed to practice in the State of North Carolina by the North Carolina Board of Nursing who also has four years of full-time accumulated experience with the IDD population; or A Master's degree in a human service field and one year of full-time, post-graduate degree accumulated experience with the IDD population; or A bachelor's degree in a human service field and two years of full-time, post-bachelor's degree accumulated experience with the IDD population; or A bachelor's degree in a field other than human services and four years of full-time, post-bachelor's degree accumulated experience with the IDD population; and For care managers serving members with LTSS needs: two years of prior LTSS and/or HCBS coordination, care delivery monitoring, and care management experience, in addition to the requirements cited above. (This experience may be concurrent with the two years of experience working directly with individuals with I/DD, or a TBI, above.) About our Line of Business ResCare Community Living, an affiliate of BrightSpring Health Services, has five decades of experience in the disability services field, providing support to individuals who need assistance with daily living due to an intellectual, developmental, or cognitive disability. We provide a comprehensive range of high-quality services, including: community living, adult host homes for adults regardless of disability, behavioral/mental health support, in-home pharmacy solutions, telecare and remote support, supported employment and training programs, and day programs. For more information, please visit ******************************* Follow us on Facebook and LinkedIn. Salary Range USD $21.64 - $26.44 / Hour