Senior Director, Quality Assurance GCP
Location: Remote, United States
Department: Quality
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 Senior Director, Quality Assurance GCP provides strategic leadership and quality oversight for the company’s clinical projects and is accountable for the GCP Quality Assurance function. This role leads the development, planning, and execution of audits and owns inspection readiness and regulatory inspection outcomes to ensure compliance with regulatory standards and company policies and procedures. The ideal candidate is comfortable working independently while leading and developing the QA GCP team and managing complex interactions with internal and external stakeholders, including CROs and regulatory authorities.
Responsibilities:
- Lead and oversee the development, planning, and execution of audits of Contract Research Organizations (CROs), clinical sites, and other service providers, ensuring compliance with Food and Drug Administration, World Health Organization, ICH‑GCP, and other applicable regulatory requirements, as well as company policies and procedures.
- Own and lead GCP regulatory inspection readiness, inspection conduct, response development, and follow‑up for FDA and other health authority inspections.
- Collaborate with Clinical Development Operations and cross‑functional stakeholders to ensure clinical studies are conducted in compliance with all applicable regulatory standards and to maintain a state of continuous inspection readiness.
- Oversee and manage the clinical quality database, including audit observations and inspection findings (e.g., 483s), to support quality trend analysis, risk assessment, and proactive compliance management.
- Organize and oversee pre‑ and post‑study document reviews and direct corrective and preventive action (CAPA) planning, implementation, and effectiveness verification.
- Manage quality events, deviations, and investigations.
- Provide senior‑level input and review of technical and clinical documents in support of clinical development programs and regulatory submissions.
- Provide leadership in the continuous improvement of GCP processes, systems, and practices across the organization.
- Monitor, review, and communicate audit and inspection outcomes, quality trends, and compliance risks to clinical and senior management.
- Oversee and conduct internal audits of the Trial Master File (TMF) to ensure GCP compliance and inspection readiness.
- Lead, develop, and evaluate the QA GCP team, including hiring, performance management, coaching, and succession planning to ensure effective operation and scalability of the function.
- Collaborate with a cross‑functional and interactive team to embed quality throughout the clinical lifecycle.
- Ability to travel to clinical sites, CROs, and vendors to support audits and inspections as needed (10–20% of time).
Qualifications:
- Bachelor’s degree in Science (required), preferably in Pharmaceutical Sciences, Technology, Life Sciences, or a related field; advanced degree preferred.
- 15+ years of relevant experience in a pharmaceutical or biotech clinical quality assurance environment, with deep expertise in GCP.
- Proven experience leading and developing QA teams and providing functional oversight in a growing organization.
- Demonstrated experience leading GCP audits and owning regulatory inspections, including direct interaction with FDA and/or global health authorities.
- Experience overseeing quality activities supporting early‑ and late‑stage clinical development programs
- Demonstrated knowledge of applicable regulations and ICH GCP guidelines.
Salary Range:
$235,000 - 275,000 USD
Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building.
Boulder, CO: Our Boulder location is home to Cogent’s discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline.
Our Offer To You
At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart. We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles. Our benefits also include a 401(k) match with immediate vesting, generous paid time off, 12 weeks of fully paid parental leave, paid family and medical leave for all employees regardless of location, and company-paid short-term disability coverage for up to 20 weeks. Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
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