Senior Manager, Quality Assurance GMP

CultureHQ

Senior Manager providing scientific leadership in Quality Control for Cogent Biosciences. Ensuring GMP compliance and supporting clinical and commercial manufacturing operations.

Posted 7/16/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $155,000 - $185,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in QC GMP activities, including method transfer, validation, and lifecycle management for drug substances and products. Proficient in analytical techniques and regulatory compliance, with strong leadership and mentoring capabilities.

Highest-signal resume keywords

Ph.D. In ChemistryQC Testing And GMP ComplianceAnalytical Techniques (HPLC/UPLC, GC)Method Validation And TransferRegulatory Requirements (FDA, EMA, ICH)

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Method TransferQualificationValidationRoot Cause AnalysisCAPA DevelopmentData ReviewAnalytical TechniquesGMP ComplianceDeviations InvestigationControl Strategies

Soft Skills

Strong Communication SkillsMentoringCollaborationInfluencing StakeholdersProblem Solving

Industry Keywords

Drug SubstanceDrug ProductQuality ControlRegulatory InspectionsContinuous ImprovementContract Testing LaboratoriesClinical ProgramsCommercial Stage ProgramsCompendial StandardsAnalytical Development

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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