Senior Manager, Product Development Quality Assurance

Role Summary

Senior Manager, Product Development Quality Assurance. Primarily responsible for directing quality oversight of AbbVie's clinical product supply, ensuring high-quality clinical materials are compliant with global regulatory requirements. Provides direction across the supply chain—from drug substance to finished product—and collaborates with interdisciplinary product development teams to identify and mitigate pipeline risks by aligning AbbVie R&D functions and external partners.

Responsibilities

• 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

• 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.

Education

• Bachelor’s degree in life sciences (biology, chemistry, or engineering) or an equivalent field.
• Master’s degree is preferred but not required based on commensurate experience.

Skills

• 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.