- 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.
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.