About the Company
Our client, a clinical-stage biotechnology company developing unique oncologic drugs treatments, is currently seeking a Director of Quality Assurance to join their growing team. The Director of Quality Assurance will be a key member of the Technical Operations team with responsibility for establishing and administering all Quality functions related to cGMP operations on site and at CMOs. The Director will provide quality oversight and support of manufacturing, testing and product distribution functions (internal and external).
- Establishing and administering of the Quality Management System
- Overseeing all quality functions related to clinical and commercial drug substance and drug product and device manufacturing at CMOs and testing facilities.
- Ensuring compliance with relevant global quality requirements
- Participating in vendor selection, assessment and qualification
- Performing risk assessments and leading investigations to address quality issues
- Recruiting, developing, and managing the Quality Assurance department as pipeline and development activities grow
Share This Position:
- BA, MS or PhD with at least 10 years’ experience in a quality assurance or related role
- Specific experience in biologics-based products required, experience with antibody-drug conjugates or devices desirable
- Demonstrated knowledge of cGMPs and relevant regulatory guidelines, both in the US and Europe
- Familiarity with ISO 13485 requirements for the design and manufacture of medical devices
- Experience at all phases of development, including commercialization
- Familiar with preparation of and guidelines for Chemistry, Manufacturing and Controls (Module 3) worldwide regulatory submissions
- Demonstrated experience of successful hiring and management of a quality or related organization / group