Senior Manager, Product Development Quality Assurance (CMC Product Lead)
AbbVie
July 02, 2026
Remote friendly (South San Francisco, CA)
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 and standards are delivered to patients. 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. Works in interdisciplinary product development teams (e.g., CMC) to identify and prevent pipeline risks by driving consensus across AbbVie R&D functions and external partners.
Responsibilities:
- Provide program oversight for the RDQA QA organization, including timely communications on strategies and issue management.
- Serve as QA representative for CMC product development teams to facilitate approval of drug to 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.
- Write/review/approve exception reports, including high-impact and complex ERs across functions.
- Manage clinical supply product actions and recalls.
- Support in-licensing and collaboration activities.
- Ensure quality agreements/contract quality aspects between R&D and third-party manufacturers, labs, and service providers.
- Interact with and influence R&D Directors/VPs and external customers; mentor staff.
Qualifications:
- Bachelor’s in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
- Master’s preferred.
- 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); investigational product experience preferred.
- Project management experience; PMP preferred but 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, including timely communications on strategies and issue management.
- Serve as QA representative for CMC product development teams to facilitate approval of drug to 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.
- Write/review/approve exception reports, including high-impact and complex ERs across functions.
- Manage clinical supply product actions and recalls.
- Support in-licensing and collaboration activities.
- Ensure quality agreements/contract quality aspects between R&D and third-party manufacturers, labs, and service providers.
- Interact with and influence R&D Directors/VPs and external customers; mentor staff.
Qualifications:
- Bachelor’s in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
- Master’s preferred.
- 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); investigational product experience preferred.
- Project management experience; PMP preferred but not required.
- Strong leadership, communication, and organizational skills.
- Ability to defend quality position and solve complex technical/quality issues.