Director of Quality Assurance, Biopharmaceuticals

1 day ago


Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time
Job Summary

We are seeking an experienced Associate Director to lead our GMP/GDP QA efforts for the development and commercialization of our products in compliance with US, EU, and ICH regulations.

Responsibilities
  • Ensure proper QA oversight and collaboration with vendors for Drug Substance (DS) and Drug Product (DP).
  • Review and approve Master Batch Production Records and Executed Batch Production Records.
  • Manage daily quality related tasks and priorities for clinical and commercial DS and DP vendors.
Requirements
  • B.S. degree in life sciences or equivalent.
  • 10+ years of GMP Quality experience with at least 3 years managing external partners.
  • Experience working with small molecule drug products.
What We Offer

A comprehensive benefits package including paid time off, summer vacation bonus, global company-wide shutdowns, annual lifestyle allowance, monthly cell phone stipend, internal rewards program, medical and dental insurance, 401(k) retirement plan with company match, and more.

About Us

Deciphera Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. Our research facility is located in Lawrence, Kansas, and our European operations are run out of Switzerland.



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