Sr/Exec Director, Quality Assurance GCP

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 inspections; 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
• Perform quality reviews of Clinical Study Documents with a focus on compliance, regulatory requirements, and risk assessment
• Align with GMP Quality Assurance and Quality Systems on the development and optimization of the quality infrastructure, systems, and policies to ensure continuity within quality operations
• Collaborate with Development, Research, and Quality Assurance colleagues to establish quality metrics and assess the state of GCP, GVP, GLP, and CDx Quality compliance across Erasca clinical studies
• Compile, track, and analyze GCP quality KPIs and vendor performance for all Erasca-initiated clinical studies, and prepare quarterly reports for quality management
• Lead, manage, develop, and mentor direct reports

Required Education and Experience

• 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
• Deep expertise in GCP Quality required, oversight of GVP, GLP, and CDx activities preferred
• Extensive knowledge of ICH GCP (E6) and other relevant ICH guidelines (including E8, E2F, and E3), as well as FDA, EMA, Health Canada (HC), PMDA, and other global regulatory requirements governing drug development, with demonstrated application of GCP and GLP principles in clinical research
• Excellent written and verbal communication skills with the ability to tailor communication to all levels and prepare and present appropriate updates to functional groups and leaders
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment
• Excellent interpersonal and influencing skills
• Strong learning orientation, curiosity, and commitment to science and patients