The Director of Quality Assurance is responsible for quality oversight for the design, construction, qualification and start-up of a new clinical phase I/II GMP manufacturing facility. This will include responsibility for recruiting, managing and developing the QA operations team that provides oversight of all activities associated with manufacturing, testing and disposition of clinical materials. The ideal candidate has hands on QA experience in all aspects of start-up and operations in a drug substance and drug product biotech manufacturing facility. Position reports to the Sr. Director of Quality.
Essential Functions and Duties
- Serve as QA lead for design, construction, commissioning, qualification and start-up of a new clinical drug substance and drug product GMP Manufacturing facility
- Recruit, manage and develop QA operations team that provides oversight of Quality Management System elements, including but not limited to deviations, Corrective and Preventive Actions (CAPA), change control and disposition in support of GMP manufacturing operations
- Develop, implement and maintain SOPs for oversight of the manufacturing, testing and release of raw materials, intermediates, drug substance and drug product
- Support preparation for and lead regulatory authority inspections and partner audits
- Develop and execute internal audit plans
- Review and approve qualification, validation and study protocols in support of investigations or changes
- Establish quality metrics program and establish Quality Management Review for the site
- Contribute to the development and implementation of the corporate strategy for GMP compliance aligned to applicable regulations and guidelines
Skills and Experience
- Bachelor’s degree in chemistry, biology, microbiology or equivalent
- Minimum 15 years of experience in the pharmaceutical/biotech industry with a minimum of 10 years’ experience in a Quality leadership position.
- Comprehensive knowledge of GMP regulations and guidelines.
- Experience in several disciplines of Quality including start-up, qualification and validation of a GMP biotech manufacturing facility
- Excellent interpersonal skills; the ability to interact effectively with all levels within the organization, external third parties, and regulatory authorities
- Effective decision-maker that has demonstrated ability to assess and manage quality and compliance risks
Interested candidates should forward a cover letter and resume/CV to firstname.lastname@example.org.