The Senior Director of Quality Assurance is responsible for the strategy, implementation and leadership of the Quality organization and is accountable for the continuous development, execution and administration of a comprehensive GxP Quality System meeting all compliance requirements pertaining to Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP), ICH and EMA regulations.
- Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
- Quality management of CMOs, CROs, contract test laboratories and other vendor services to ensure compliance with manufacturing and testing of company products.
- Establish and maintain phase appropriate GMP compliance for product manufacturing, testing, and stability; ensure appropriate review and assessment of production records, in-process and release testing methods, specifications, validations, reference materials and test results.
- Review and edit Quality Agreements, contracts, supply agreements, etc., provide quality input to project/program plans, master service agreements and statements of work.
- Provide operational leadership and expertise in the development, implementation, and training of cGMP compliant quality systems, such as document control, change control, investigations, deviations, CAPA, and product/customer complaints.
The ideal candidate will have the following skill set:
- Experience managing CMO/CRO relationships and projects
- Demonstrated knowledge of US and EU cGMPs
- Extensive experience in the biotechnology or biopharmaceutical manufacturing industry with prior experience in QA focused on gene therapy (AAV or LVV preferred)
- Excellent written and verbal communication skills, analytic and problem-solving
- BA/BS/University degree in Life/Health Sciences required( advanced degree preferred).
