Backed by GV.
About the role
The Director, GMP QA Operations will serve as the GMP Quality lead for assigned clinical and commercial products and programs. This position will provide Quality oversight across the external manufacturing and supply network, including Drug Substance (DS), Drug Product Intermediates (DPI), Drug Product (DP), Finished Product (FP), and Packaged Product.
What they're looking for
- Bachelor's degree in a scientific or technical discipline is required
- A minimum of 12+ years of experience in GMP Quality in the pharmaceutical industry is required with focus on small molecule manufacturing, with 5 years managerial experience in GMP area
- Significant experience supporting clinical, late-stage and commercial pharmaceutical manufacturing
- Strong experience with batch record review, batch release, and product disposition
- Experience providing Quality oversight of CMOs, CDMOs, testing laboratories, packaging sites, and suppliers
- Experience with Drug Substance and Drug Product manufacturing. Experience with oral solid dosage forms is preferred
More about this role
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.
Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.
The Director, GMP QA Operations will serve as the GMP Quality lead for assigned clinical and commercial products and programs. This position will provide Quality oversight across the external manufacturing and supply network, including Drug Substance (DS), Drug Product Intermediates (DPI), Drug Product (DP), Finished Product (FP), and Packaged Product.
The Director will be responsible for GMP...
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