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

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.

Requirements

• 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.

Benefits

• paid time off
• medical/dental/vision insurance
• 401(k)