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.

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