Sr​/Exec Director, Quality Assurance GCP

Erascais 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

AssuranceGCPwill lead GCPactivities and have responsibility for strategic and tactical oversight and implementation of QAGCPoperations in support of Erasca’sclinical development programs (Phase1, 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 operationsteamsto executeGCP, GLP, GVP, andCDxstrategies andparticipatein the further development of a high functioning Quality organization.

• Ensure strategic and tactical clinical quality oversight ofall
  
  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, andGLP 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
  
  DocumentsandprovideQA 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, supporttimelyreview 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 sitesand training staff on regulatory inspection management best practices
• Represent Clinical Quality during global regulatory inspections at Erasca including supporting regulatory inspections atglobalclinical 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, andCDxvendors comply with applicable quality program sand regulationsor guidelines and are prepared for Regulatory inspections
• Align withGMP Quality Assurance and Quality Systemson the developmentandoptimization ofthequality 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, andCDxQuality compliance across Erasca…