Senior Manager, Quality Control

Job Summary

To support quality control activities in biologics, the full-time Senior Manager, Quality Control will oversee QC operations across CDMOs and contract testing labs in a remote environment, ensuring compliance with cGMP and regulatory standards while managing analytical strategies and data integrity.

Key Responsibilities

• Coordinate and support QC activities at CDMOs and contract laboratories to ensure alignment with established plans
• Review and approve analytical data for in-process, release, and stability testing
• Lead method transfer, qualification, validation, and lifecycle management

Required Qualifications

• Ph.D., MS, or BS in Biochemistry, Molecular Biology, Biotechnology, or related field
• 8-10 years of experience in biologics QC, Analytical Development, or Quality
• Strong experience managing CDMOs and contract labs in a virtual biotech/pharma model
• Proven track record supporting global regulatory filings and inspections
• Extensive experience with IND, BLA, MAA, and post-approval submissions