Associate Director, Quality Assurance GCP

About the role

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. The company's lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations within the KIT receptor tyrosine kinase, including KIT D816V. This mutation drives Systemic Mastocytosis and is also present in gastrointestinal stromal tumors (GIST), where tumors show strong dependence on oncogenic KIT signaling. Bezuclastinib has demonstrated promising initial data across three key trials - APEX in AdvSM, SUMMIT in NonAdvSM, and PEAK in GIST - with an encouraging safety profile across 600+ patients in single agent and combination dosing.

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 ensures compliance with applicable regulatory requirements and company procedures while fostering a culture of quality across clinical operations and development teams. The position partners closely with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, and external service providers to maintain inspection readiness and ensure clinical trials are conducted in accordance with GCP standards. The ideal candidate operates independently while managing complex interactions across internal and external stakeholders.

What you'll do

• 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.

Requirements

• 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 guidelines, including FDA, EMA, ICH-GCP, and other global regulatory requirements.
• Experience working with and overseeing CROs and external vendors supporting clinical programs.
• Proven ability to manage quality investigations, CAPAs, and inspection readiness activities.
• Strong problem-solving skills and ability to operate effectively in a fast-paced, evolving environment.
• Excellent written and verbal communication skills, with the ability to clearly communicate risks, findings, and recommendations to cross-functional stakeholders.
• Ability to work independently while collaborating effectively across teams and influencing without direct authority.

Compensation and location

This role is based in the United States as a remote position. The salary range is $180,000-$205,000 USD, with target bonus of 20%. Exact compensation will vary based on skills, experience, and location.

Our locations

• Waltham, MA: Headquarters in the Greater Boston life sciences community, featuring an open, collaborative office environment with on-site amenities including free parking and gym facilities.
• Boulder, CO: Home to Cogent's discovery research organization and a key scientific hub within the Denver-Boulder biopharmaceutical corridor, driving advancement of discovery efforts and pipeline programs.