Associate Director, Quality Assurance GCP

Who We Are:

• Cogent Biosciences is a publicly traded biotechnology company developing novel precision therapies.
• We focus on rare conditions like Systemic Mastocytosis and GIST, with promising clinical data.
• Our culture is collaborative, innovative, and committed to patient impact.

The Role:

• The Associate Director, Quality Assurance GCP provides strategic leadership for GCP quality activities.
• You will ensure compliance with regulatory requirements and support a culture of quality.
• You will partner with Clinical Development, Operations, and external vendors to maintain inspection readiness.

What You'll Do:

• Lead GCP audits and regulatory inspection readiness.
• Manage quality events, CAPAs, and quality systems.
• Mentor junior QA staff and serve as a key quality resource.

Benefits:

• 100% coverage of medical, dental, and vision premiums for you and your family.
• 12 weeks of fully paid parental leave and 401(k) match with immediate vesting.
• Additional perks like wellness programs, tuition reimbursement, and family-forming support.