Senior Manager, Product Development Quality Assurance (CMC Product Lead)
AbbVie
July 02, 2026
Remote friendly (North Chicago, IL)
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. 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 through consensus-building across 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 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 during inspections/audits.
- Write, review, and approve exception reports, including high-impact and complex ERs across functional areas.
- Manage clinical supply product actions and recalls.
- Support in-licensing and collaboration activities.
- Ensure appropriate quality agreements/quality contract aspects with R&D, third-party manufacturers/labs, and service providers/sites.
- Interact with and influence decisions of R&D directors/VPs; mentor staff.
Qualifications:
- Bachelor’s degree (life sciences such as biology/chemistry/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.
- Strong understanding of GMP requirements (D, EU, US), pharmaceutical manufacturing (chemical/biological), and analytical sciences; experience with investigational products 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 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 during inspections/audits.
- Write, review, and approve exception reports, including high-impact and complex ERs across functional areas.
- Manage clinical supply product actions and recalls.
- Support in-licensing and collaboration activities.
- Ensure appropriate quality agreements/quality contract aspects with R&D, third-party manufacturers/labs, and service providers/sites.
- Interact with and influence decisions of R&D directors/VPs; mentor staff.
Qualifications:
- Bachelor’s degree (life sciences such as biology/chemistry/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.
- Strong understanding of GMP requirements (D, EU, US), pharmaceutical manufacturing (chemical/biological), and analytical sciences; experience with investigational products 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.