💼 About This Role

You'll lead the global GCP quality strategy for a late-stage oncology company developing RAS-targeted therapies. Your oversight will ensure compliance and inspection readiness across Phase 2/3 studies, directly impacting regulatory success and patient safety.

🎯 What You'll Do

• Develop and execute global GCP QA strategy aligned with corporate objectives.
• Provide QA oversight for global Phase 2/3 oncology studies.
• Lead GCP audit and inspection activities, ensuring CAPA resolution.
• Oversee vendor and CRO quality management and compliance.

📋 Requirements

• Advanced degree in life sciences or related field.
• Minimum 15 years in pharma/biotech with 10+ years in GCP QA leadership.
• Demonstrated experience leading regulatory inspections (FDA, EMA, etc.).
• Experience supporting late-stage clinical development and submissions.

✨ Nice to Have

• Experience implementing risk-based quality management frameworks.
• Expertise in oncology clinical trials.

🎁 Benefits & Perks

• 🏖️ Comprehensive benefits package including health, dental, and vision insurance.
• 💰 Competitive salary and equity based on experience.
• 🏢 Redwood City headquarters with collaborative culture.
• 🔄 Opportunity for professional growth in a late-stage biotech.

📨 Hiring Process

Estimated timeline: 4-6 weeks · AI estimate

1. 1Phone Screen· 30 min
2. 2Technical Interview· 60 min
3. 3Onsite Interview· Full day