Job Description
📋 Description Ensure strategic and tactical QA oversight of Erasca clinical programs. Oversee global Ph3 trials and readiness for commercialization. Establish quality policies to meet GCP, GVP, GLP and policies. Represent clinical QA on project teams; provide QA guidance. Lead QA Audit and Clinical Inspections staff; hire and mentor. Manage external GCP auditors; CAPA planning and tracking. 🎯 Requirements 12+ years in pharma/biotech quality with progressive leadership. Deep GCP, GLP, CDx QA; regulatory inspections experience. Experience with registrational trials and transition to commercial quality. Expertise in ICH GCP guidelines (E6) and FDA/EMA/HC/PMDA rules. Excellent written and verbal communication; ability to influence at all levels. Undergraduate degree in Biology, Chemistry, or Physical Sciences (preferred). 🎁 Benefits Paid time off, holidays, and sick leave Medical, dental, and vision plans Short- and long-term disability coverage 401(k) with Erasca contribution; Employee Stock Purchase Plan Flexible spending accounts (FSA/HSA) and commuter benefits Life/AD&D, critical illness and pet insurance
