Director of Quality Control
An innovative biotech company in the Bay is seeking a Director of Quality Control to join its growing team! This publicly held company recently had its stock grow substantially as they continue to build out their diverse pipeline of novel technology.
The Director of Quality Control will have the following responsibilities:
- Ensures contract laboratory cGMP and GLP compliance and adherence to current FDA Guidelines, ICH, and foreign regulations in the areas of microbiology, chemistry, methods validation and stability.
- Interact with customers, contract laboratories, auditors and regulatory agencies. Support agency and other third party inspections.
- Ensures current knowledge and implementation of FDA/ICH guidance documents and USP/EP requirements.
- Review and responds to third party customer audits.
- Review and approve raw material, finished product and stability test data generated in the Quality Control Laboratory
- Responsible for the timely hiring, training and development of qualified staff to ensure effective testing, execution of roles and responsibilities, GMP and GLP compliance, and attainment of operational and development goals.
- Collaborate with Quality Assurance, Validation, Product Development, and Manufacturing Personnel to resolve production problems.
- Recommend laboratory capital improvements.
The ideal candidate will have the following skill set:
- Bachelors at a minimum with 6+ years of senior-level QC experience
- Drug substance and/or drug product experience
- Experience overseeing vendors / contract sites