Senior Manager, Quality Assurance GMP

Responsibilities

• Provide scientific leadership for QC GMP activities, including method transfer, qualification, validation, and lifecycle management for drug substance (DS) and drug product.
• 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.

Qualifications

• 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.

Pay

Salary Range: $155,000 - 185,000 USD
Target Bonus: 15%

Benefits

Our benefits package includes:

• 100% coverage of medical, dental, and vision premiums for you and your family.
• Funding up to 75% of in-network deductibles.
• 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.
• Company-paid short-term disability coverage for up to 20 weeks.
• Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support.