Senior Manager, Quality Assurance GMP
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Job Description
Senior Manager providing scientific leadership in Quality Control for Cogent Biosciences. Ensuring GMP compliance and supporting clinical and commercial manufacturing operations.
Responsibilities:
- Provide scientific leadership for QC GMP activities, including method transfer, qualification, validation, and lifecycle management for drug substance (DS) and drug product (DP).
- Serve as a QC subject-matter expert supporting release and stability testing, including data review, trending, and interpretation.
- Lead or support investigations of deviations, OOS, and OOT results, including root cause analysis and development of corrective and preventive actions (CAPAs).
- Collaborate closely with Analytical Development and CMC teams to ensure successful method transfers to QC laboratories and external CMOs.
- Provide oversight of QC activities conducted at contract testing laboratories and manufacturing partners, including review of data packages and ensuring compliance with quality and regulatory requirements.
- Contribute to the development and execution of control strategies for small-molecule drug substance and drug product.
- Author, review, and approve QC-related documents, including methods, specifications, protocols, validation reports, and regulatory submission content.
- Support regulatory inspections and audits, including preparation, response, and follow-up activities.
- Identify opportunities for continuous improvement in QC processes, technologies, and compliance practices.
- Mentor junior staff and serve as a technical resource across functional teams.
Requirements:
- Ph.D. in Chemistry, Pharmaceutical Sciences, or a related discipline, with significant experience in QC or analytical sciences in a GMP environment; or M.S./B.S. with substantial relevant industry experience.
- 5-8 years of experience with QC testing and GMP compliance supporting clinical and/or commercial stage programs.
- Strong expertise in analytical techniques relevant to small-molecule pharmaceuticals (e.g., HPLC/UPLC, GC, dissolution, spectroscopic methods, and wet chemistry).
- Deep understanding of method validation, transfer, and lifecycle management in a regulated environment.
- Demonstrated experience supporting or leading deviation investigations (OOS/OOT) and CAPA processes.
- Working knowledge of global regulatory requirements, including FDA, EMA, ICH guidelines, and compendial standards (USP, EP).
- Experience working with and overseeing external laboratories, CMOs, or CROs.
- Proven ability to operate independently, manage multiple priorities, and influence cross-functional stakeholders.
- Strong written and verbal communication skills, with the ability to clearly present technical concepts and data.
Benefits:
- Health insurance
- 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
- Company-paid short-term disability coverage for up to 20 weeks
- Wellness programs
- Tuition reimbursement
- Inclusive family-forming support
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