Senior Manager, Product Development Quality Assurance (CMC Product Lead)
AbbVie
July 02, 2026
Remote friendly (Worcester, MA)
United States
$124,500 - $236,500 USD yearly
Operations
Primarily responsible for supporting AbbVie’s pipeline by ensuring high-quality clinical supplies compliant with global regulatory requirements are delivered to patients. The Senior Manager, Clinical Product Supply provides direction and quality oversight of the supply chain, including manufacturing, testing, and release processes from drug substance to drug product to finished product. As part of interdisciplinary product development teams (e.g., CMC teams), drives early identification and prevention of pipeline risks by building consensus across AbbVie R&D functions and external partners.
Responsibilities:
- Provide program oversight for the RDQA QA organization; timely communications on program strategies and issue management.
- Serve as QA representative for CMC product development teams to facilitate drug approval for clinical trials per timelines.
- Lead complex global cross-functional process improvement teams.
- Provide innovative, risk-based solutions to complex technical problems.
- Support regulatory inspections and internal audits; represent Quality in inspections and audits.
- Write/review/approve exception reports, including high-impact, complex ERs across functional areas.
- Manage clinical supply product actions and recalls.
- Support in-licensing and collaboration activities.
- Ensure suitable quality agreements/contract quality aspects with R&D and third-party manufacturers, labs, service providers, and sites.
- Interact/influence decisions of R&D Directors and VPs; mentor staff.
Qualifications:
- Bachelor’s (typically life sciences such as biology, chemistry, or engineering) and/or equivalent experience.
- Master’s preferred (not required).
- 8+ years industry experience in Quality Assurance, production, testing of APIs/drug products, drug development, or related healthcare field.
- Broad understanding of pharmaceutical manufacturing (chemical/biological), analytical sciences, and GMP requirements (global: US, EU, and others). Investigational product experience preferred.
- Project management experience; PMP preferred (not required).
- Strong leadership, communication, and organizational skills.
- Ability to defend quality position and solve complex technical/quality issues.
Responsibilities:
- Provide program oversight for the RDQA QA organization; timely communications on program strategies and issue management.
- Serve as QA representative for CMC product development teams to facilitate drug approval for clinical trials per timelines.
- Lead complex global cross-functional process improvement teams.
- Provide innovative, risk-based solutions to complex technical problems.
- Support regulatory inspections and internal audits; represent Quality in inspections and audits.
- Write/review/approve exception reports, including high-impact, complex ERs across functional areas.
- Manage clinical supply product actions and recalls.
- Support in-licensing and collaboration activities.
- Ensure suitable quality agreements/contract quality aspects with R&D and third-party manufacturers, labs, service providers, and sites.
- Interact/influence decisions of R&D Directors and VPs; mentor staff.
Qualifications:
- Bachelor’s (typically life sciences such as biology, chemistry, or engineering) and/or equivalent experience.
- Master’s preferred (not required).
- 8+ years industry experience in Quality Assurance, production, testing of APIs/drug products, drug development, or related healthcare field.
- Broad understanding of pharmaceutical manufacturing (chemical/biological), analytical sciences, and GMP requirements (global: US, EU, and others). Investigational product experience preferred.
- Project management experience; PMP preferred (not required).
- Strong leadership, communication, and organizational skills.
- Ability to defend quality position and solve complex technical/quality issues.