Senior Manager, Product Development Quality Assurance (CMC Product Lead)

Primarily responsible for supporting AbbVie’s pipeline by ensuring high-quality clinical supplies compliant with global regulatory requirements are delivered to patients. Provides direction and quality oversight of the supply chain, including manufacturing, testing and release processes from drug substance to finished product.

Requirements

• Provide program oversight for the RDQA QA organization
• 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
• Write/review/approve exception reports
• 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
• Interact and influence decisions of R&D Directors and VP as well as external customers and mentor staff
• Provide quality position and effectively problem solve complex technical and quality issues

Benefits

• Paid time off
• Medical/dental/vision insurance
• 401(k)