Sr/Exec Director, Quality Assurance GCP
About the 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.
Position Summary
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.
Essential Duties and Responsibilities
- Ensure strategic and tactical clinical quality oversight of all Erasca clinical programs
- Provide seamless Quality oversight of global Ph3 trials and assure readiness for commercialization and launch
- Establish quality policies and procedures to ensure systems align with applicable GCP, GVP, and GLP global health authority regulations, guidance, and corporate policies
- Provide quality and compliance input and guidance to partners and stakeholders to achieve continuous quality improvement and effective quality controls
- Represent clinical QA on project and study teams, perform technical review of Clinical Study Documents