Sr/Exec Director, Quality Assurance GCP

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.

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., DSUR), other subject-facing documents (brochures, recruitment materials), Investigator’s Brochure, and CSR

In collaboration with function heads, ensure GCP, GVP, GLP, and CDx vendors comply with applicable quality programs and regulations or guidelines and are prepared for Regulatory inspections

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

Conduct gap analysis and risk assessment for critical study level activities that may impact subject safety and/or the quality and reliability of data, including but not limited to: Study Design and Protocol Requirements, Clinical Vendors and Service Providers-Transferred Obligations, contractual duties per SOW, and overall performance, Internal processes (e.g., vendor oversight), and Clinical Site and PI assessment and performance.

Escalate quality events, IPDs, potential serious breaches to relevant leadership as needed and in a timely manner including initiating CAPAs and CIs to address major findings and gaps.

Lead, manage, develop, and mentor direct reports

Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations

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…