Associate Director, Quality Assurance GCP

Who We Are

Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.

The Role

The Associate Director, Quality Assurance GCP provides strategic leadership and oversight of Good Clinical Practice (GCP) quality activities in support of Cogent’s clinical development programs. This role is responsible for ensuring compliance with applicable regulatory requirements and company procedures, while supporting a culture of quality across clinical operations and development teams.

This position partners closely with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, and external service providers to maintain inspection readiness and ensure that clinical trials are conducted in accordance with GCP standards. The ideal candidate is comfortable working independently while managing complex interactions across internal and external stakeholders.

Responsibilities

• Provide strategic leadership and oversight for GCP quality assurance activities supporting clinical development programs.
• Lead the development, planning, and execution of GCP audits, including audits of clinical sites, CROs, vendors, and internal processes.
• Own and drive regulatory inspection readiness, including preparation for FDA and other health authority inspections, inspection conduct, and response to findings.
• Collaborate with Clinical Development and Clinical Operations teams to ensure studies are conducted in compliance with applicable GCP, regulatory requirements, and company SOPs.
• Provide expert guidance in the identification, investigation, and resolution of quality events, including deviations, CAPAs, and audit findings.
• Oversee and maintain the GCP quality systems, including processes for audit tracking, issue management, and quality metrics.
• Contribute to the development, implementation, and continuous improvement of quality systems, SOPs, and policies to support GCP compliance.
• Support cross-functional teams in the preparation and review of clinical documents and regulatory submissions from a quality perspective.
• Manage relationships with external vendors and partners to ensure quality expectations are clearly defined and met.
• Provide mentorship and guidance to junior QA staff and serve as a key quality resource across the organization.

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred.
• 8-10 years of experience in GCP Quality Assurance within the pharmaceutical or biotechnology industry.
• Demonstrated experience leading or supporting regulatory inspections (e.g., FDA, EMA) and audit programs.
• Strong understanding of GCP regulations and guidance...