About the Company
Our client, a biotechnology company focused on unique, revolutionary treatments for patients is currently seeking an Associate Director, QA for their Lexington location. The Associate Director of QA Oversees the development, implementation and maintenance of quality assurance systems, leads initiatives in support of the company goals and implements continuous improvements, including all aspects of GMP and (GXP) compliance.
- Recommending and providing leadership and planning for the implementation of quality assurance (QA) policies and programs.
- Overseeing generation and review of documents used in good manufacturing practices.
- Monitoring internal audits of Production, Quality Control, Manufacturing and Development areas.
- Overseeing the vendor audits program.
- Reviewing and approving reports and other documentation prepared by Development, Production, QA and QC for regulatory submissions and inspections.
- Assuring finished products are dispositioned in accordance to defined regulatory requirements and satisfy GXP regulations.
- Working with CMO & CRO partners to ensure trouble free pre-approval and regular Regulatory inspections and interactions.
- Assisting in the development of and leading the implementation of Global Quality System
- Leading risk assessment discussions to define document and integrate risk management into.
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- Requires BS in chemistry, biology or equivalent science, Master’s degree in science and/or management preferred
- 8 -10 years plus Quality Assurance Management and GXP experience.