Sr/Exec Director, Quality Assurance GCP

📋 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