Sr/Exec Director, Quality Assurance GCP

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 and provide QA guidance on quality compliance issues, regulatory risk, and process improvements - Develop a risk-based GCP audit program and compliance strategy for Erasca clinical study programs - Prepare and lead GCP and GVP inspection; eventually hire, develop, and mentor QA Audit and Clinical Inspections staff - Manage external GCP auditors, support timely review of audit reports, and communicate findings to auditees, cross-functional representatives, and management. Ensure corrective and preventative action (CAPA) plans adequately address findings and root causes, including effectiveness checks where appropriate - Support global regulatory, due diligence, and partner inspections including preparing sites and training staff on regulatory inspection management best practices - Represent Clinical Quality during global regulatory inspections at Erasca including supporting regulatory inspections at global clinical sites for Erasca clinical studies - Work with Clinical Operations to oversee study documentation, including TMF, for accuracy and inspection readiness - Perform quality reviews of Clinical Study Documents with a focus on compliance, regulatory requirements, and risk assessment. The study documents include but are not limited to: Study Protocols, ICFs, Annual Reports (e. g.