Cogent Biosciences

Cogent Biosciences

Associate Director, Quality Assurance GCP

Remote, United States · Director

Sponsorship not specified$180k-$205kDetected 6 days ago
GCPClinical TrialsFDA RegulatoryResearchLeadershipCommunicationProblem SolvingMentoringGxPRegulatory Affairs

About the role

  • The ideal candidate is comfortable working independently while managing complex interactions across internal and external stakeholders.

Responsibilities

  • Lead the development, planning, and execution of GCP audits, including audits of clinical sites, CROs, vendors, and internal processes.
  • Collaborate with Clinical Development and Clinical Operations teams to ensure studies are conducted in compliance with applicable GCP, regulatory requirements, and company SOPs.
  • 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.
  • 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.
  • 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.

Requirements

  • 8-10 years of experience in GCP Quality Assurance within the pharmaceutical or biotechnology industry.
  • 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.
  • 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.
  • Demonstrated experience leading or supporting regulatory inspections (e.g., FDA, EMA) and audit programs.
  • Proven ability to manage quality investigations, CAPAs, and inspection readiness activities.

Nice to have

  • Bachelor's degree in a scientific discipline required
  • advanced degree (MS, PharmD, PhD) preferred.

Compensation

  • $180,000 - 205,000 USD
  • Exact compensation will vary based on skills, experience, and location.
  • At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that se t s us apart.

Benefits

  • At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that se t s 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.
  • A dditional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.

Company info

  • 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.
  • 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.
  • 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.
  • Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection.
  • We are proud to be an

Equal opportunity

  • We are proud to be an Equal Opportunity Employer.
  • Our goal is to have a diverse workforce.
  • Equal Opportunity Employer.
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