Senior Manager, Product Development Quality Assurance

Role Summary

Primarily responsible for supporting AbbVie's pipeline by ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. The Senior Manager, Product Development Quality Assurance 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 a member of 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

• 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.
• 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.

Education

• Bachelor’s degree, typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
• Master’s degree is preferred but not required based on commensurate experience.
• Project Management Professional (PMP) certification is preferred, but not required.