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

Responsibilities:
- Provide program oversight for the RDQA QA organization; manage timely communications on program strategies and issue management.
- Serve as QA representative for CMC product development teams to facilitate approval of drugs to clinical trials per program 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 in inspections/audits.
- Write/review/approve exception reports, including high-impact, complex ERs across functional areas.
- Manage clinical supply product actions and recalls.
- Support in-licensing and collaboration activities.
- Ensure appropriate quality agreements/contract quality aspects between R&D and third-party manufacturers, labs, service providers, and other sites.
- Interact with/influence R&D leadership and external customers; mentor staff.

Qualifications:
- Bachelor’s degree (typically life sciences such as biology, chemistry, or engineering) or equivalent experience.
- Master’s degree preferred (not required).
- 8+ years industry experience in Quality Assurance, production/testing of APIs or drug products, drug development, or related healthcare field (less with advanced degree).
- Broad understanding of pharmaceutical manufacturing processes (chemical/biological), analytical sciences, and GMP requirements (global: US/EU and others); investigational product experience preferred.
- Project management experience; PMP certification preferred (not required).
- Strong leadership, communication, and organizational skills.
- Ability to defend the quality position and solve complex technical/quality issues.