Senior Manager, Product Development Quality Assurance

Company: AbbVie
Location: Worcester
Posted on: March 5, 2026

Job Description:

Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description Primarily responsible for supporting AbbVies pipeline, by ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. The Senior Manager, Clinical Product Supply is primarily responsible for providing direction and quality oversight of the supply chain, including manufacturing, testing and release processes from drug substance to drug product to finished product. As a team member in interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus-building across AbbVie R&D functions and external partners. Responsibilities List up to 10 main responsibilities for the job. Include information about the accountability and scope. Provide program oversight for the RDQA QA organization; includes timely communications on program strategies and issue management. QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines Lead complex global cross-functional process improvement teams. Provide innovative and risk-based solutions to complex technical problems. Support the preparation of regulatory inspections and internal audits, and represent Quality in inspections and audits. Write/ review/ approve exception reports, including high impact and complex ERs impacting multi-functional areas. Provide management of clinical supply product actions and recalls. Support in-licensing and collaboration activities. Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, and other service providers and other sites. Interact and influence decisions of the various R&D Directors and VP as well as external customers and mentor staff. Qualifications Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience. Masters degree is preferred but is not required based on commensurate experience. 8 years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree. Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is required. Experience applicable to investigational products is preferred. Experience in project management and ability to manage multiple priorities. Project Management Professional (PMP) certification is preferred, but not required. Strong leadership, communication, and organizational skills. Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this postingbased on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore orless than the posted range. This range may bemodifiedin thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible toparticipatein our short-term incentiveprograms. Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paidandmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Keywords: AbbVie, Marthas Vineyard , Senior Manager, Product Development Quality Assurance, Healthcare , Worcester, Massachusetts