Director, Quality Control
On-site · Rockville, Maryland, United States
Job Summary
Leads Quality Control operations in a cGMP laboratory, providing in-depth technical and scientific guidance to lab supervisors and analysts to ensure data generation, testing, review, and documentation of materials (including APIs, excipients, raw materials, finished products, and stability samples) per ALCOA principles. Oversees investigations, regulatory compliance (GMP, NIH, ICH, FDA), and cross-functional collaboration; supports regulatory filings (IND, BLA, MAA); emphasizes staff development and a data-centric, compliant culture. Requires a Bachelor’s degree in a science discipline and 10+ years in biopharma with 8+ years in supervisory roles.
Required Qualifications
- Bachelor’s degree in a science discipline
- 10+ years industrial experience in biopharmaceutical industry
- 8+ years supervisory and managerial experiences
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