GCP QA Strategy Lead (Remote)

Cogent Biosciences; United States; Remote; USD 123,000 - 205,000; Full time

Benefits offered by this job

Bonus

Stock awards

Medical, dental, vision coverage

401(k) match

Paid time off

Parental leave

Disability coverage

Tuition reimbursement

Family-building support

Job summary

Cogent Biosciences is seeking an Associate Director of Quality Assurance GCP to lead quality activities across clinical development. Remote, United States.

The role focuses on ensuring GCP compliance, directing audits of sites and CROs, and maintaining inspection readiness with FDA and other authorities. The ideal candidate will have 8–10 years in GCP QA, a strong regulatory background, and proven ability to guide quality improvements across cross‑functional teams.

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 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.

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.

Skills

GCP QA

Regulatory inspections

Audit programs

Quality systems

Cross-functional

Education

Bachelor's in science

MS/PhD preferred

Job description

Cogent Biosciences is seeking an Associate Director of Quality Assurance GCP to lead quality activities across clinical development. Remote, United States.

The role focuses on ensuring GCP compliance, directing audits of sites and CROs, and maintaining inspection readiness with FDA and other authorities. The ideal candidate will have 8–10 years in GCP QA, a strong regulatory background, and proven ability to guide quality improvements across cross‑functional teams.