Erasca is a clinical-stage precision oncology company driven by a bold mission—to erase cancer. Backed by a16z.
About the role
Reporting to the Chief Operating Officer, the Senior or Executive Director Quality Assurance GCP will lead GCP activities and have responsibility for strategic and tactical oversight and implementation of QA GCP operations in support of Erasca’s clinical development programs (Phase 1, 2, 3), regulatory submissions, and planned future commercial launches.
What they're looking for
- Undergraduate degree in Biology, Chemistry, Physical Sciences, or related discipline preferred
- 12+ years of experience including management of GCP Quality in a pharmaceutical or biotech environment in progressively responsible Quality roles required
- Experience with quality for registrational clinical trials required, transition from clinical stage to commercial quality systems highly preferred
- Experience with the application of phase-appropriate quality systems across the product development lifecycle and on to commercial launch highly preferred
- Experience in regulatory inspections required, experience interacting with global regulatory agencies through the drug product approval process preferred
- Extensive experience participating in regulatory agency inspections of global clinical research activities
More about this role
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.
Reporting to the Chief Operating Officer, the Senior or Executive Director Quality Assurance GCP will lead GCP activities and have responsibility for strategic and tactical oversight and implementation of QA GCP operations in support of Erasca’s clinical development programs (Phase 1, 2, 3), regulatory submissions, and planned future commercial launches. As a key member of the Quality Assurance leadership team, this person will partner with relevant clinical development and operations teams to execute GCP, GLP, GVP, and CDx strategies and participate in the further development of a high functioning Quality organization.
- Ensure...
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