Manager, QA
- Oversee all aspects of cGMP CMC quality compliance for investigational and commercial drugs, including third party manufacturer oversight strategy and management and QA Agreement implementation
- Assign lot disposition for active pharmaceutical ingredients, drug products, clinical trial materials, and commercial products
- Develop and maintaining a vendor qualification and audit program, annual cGMP training and annual product reports
- Implement phase appropriate quality systems for both investigational and commercial CMC activities plus other GXP activities as needed; and represent QA on development teams; and working with other GXP functional areas (GLP and GCP) as needed.
Requirements:
The candidate must have broad experience across GXP QA functional areas including development and maintenance of quality systems. In particular, the candidate must possess a good working knowledge of cGMPs. Knowledge of quality systems and regulatory compliance requirements with in both investigational and commercial manufacturing phases is a must. Travel required. Education: Bachelor’s degree or equivalent experience in a CMC QA decision making capacity with 10+ years in an FDA regulated industry, preferably in a small molecule drugs.