The QA Director manages cGMP and compliance activities while leading the quality team to successfully support manufacturing and supply chain operations in a timely and compliant manner.
In this role, you will:
- Ensure cGMP Compliance in the day-to-day operations performed at the Company facility encompassing the manufacturing, handling, packaging, labeling, storage, and distribution of components and drug products.
- Overall responsibility for cGMP documented processes such as: sampling and disposition of components, labels, in-process material, and finished products, inspection of production lines, and review of analytical and production batch records.
- Oversight and management of Quality Systems such as deviation and complaints.
- Identify resources needed to achieve assigned responsibilities and manage expenses.
- Obtain and report KPIs and identify improvements to ensure safety, compliance, and efficiency.
- Support regulatory inspections and audits.
Education and Experience:
- A bachelor's degree in Science.
- 10-15 ten years of experience in pharmaceutical industry, preferably small molecule.
- 7-10 years as a Quality Lead in a cGMP environment.
- Familiarity with USP General Chapters and USP Monograph testing.
- Familiarity auditing process and interaction with governmental agencies (e.g., FDA, DEA, BOP, etc.)