Actalent
Brockton, MA
Description The Director of Quality Assurance has overall responsibility for providing leadership and direction for all Quality Assurance programs and for ensuring compliance with all relevant FDA regulations and guidelines as they pertain to marketed drug products. This includes overseeing the preparation and approval of master batch documents, SOPs, specifications and protocols. Also responsible for the release of raw materials, packaging components, in-process and finished products. In addition, duties include coordination of GMP training and internal and vendor compliance audits, oversight of validation projects, facility / process and equipment change control, investigation of procedural deviations, nonconformances, customer complaints and environmental anomalies. Primary liaison for client and regulatory audits. The Director of Quality Assurance has responsibility for the company's Quality Management System; and for the assurance of drug quality, strength, identity, and...

