Responsibilities of the QA Manager:
- Lead initiatives for the development, deployment, and management of Quality System (Document Management, Investigations, Corrective and Preventative Actions, Change Control, Technology Transfer, etc.
- Develop, review, contribute and approve Policies and SOPs in support of the Quality Systems Manual and other functional areas.
- Manage any regulatory or governing body certifications (CLIA).
- Manage change control, CAPA, deviation, and investigation programs.
- Review and approve executed documents including validation documents, reports that could be filed in support of regulatory submissions, and operating procedures.
- Oversee the internal and external audit program, which includes, focus on GxP, GLP, GCP, CLIA compliance.
Requirements of the QA Manager:
- BS or MS degree and 5+ years QA GxP experience in biotech/pharmaceutical environment working with various quality systems and CMOs is required.
- GCP and GLP experience is preferred.
- Demonstrated success managing quality systems such as, deviations, change controls, etc.
- Experience with quality/compliance oversight of clinical through product commercialization.
- Possess in-depth knowledge of FDA and international GxP regulations, guidance, principles, concepts, and industry best practices.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.