Senior Manager, Quality Control, GMP

Job not on LinkedIn

🕒 July 16

🇺🇸 United States – Remote

💵 $155k - $185k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 36%

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CultureHQ

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2017

☁️ SaaS

SaaS

CultureHQ is a web-based application; the provided text only indicates that the application requires JavaScript to run. No additional information about the company's offerings, target customers, or industry was provided.

📋 Description

• Provide scientific leadership for QC GMP activities, including method transfer, qualification, validation, and lifecycle management for drug substance 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 CAPA development • Collaborate with Analytical Development and CMC teams on method transfers to QC laboratories and external CMOs • Oversee QC activities at contract testing laboratories and manufacturing partners • Review data packages and ensure compliance with quality and regulatory requirements • Contribute to control strategies for small-molecule drug substance and drug product • Author, review, and approve QC-related documents and regulatory submission content • Support regulatory inspections and audits • Identify continuous-improvement opportunities 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 QC or analytical sciences experience 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, including HPLC/UPLC, GC, dissolution, spectroscopic methods, and wet chemistry • Deep understanding of method validation, transfer, and lifecycle management in a regulated environment • Experience supporting or leading deviation investigations, OOS/OOT results, and CAPA processes • Working knowledge of FDA, EMA, ICH guidelines, and USP/EP compendial standards • Experience working with and overseeing external laboratories, CMOs, or CROs • Ability to operate independently, manage multiple priorities, and influence cross-functional stakeholders • Strong written and verbal communication skills and ability to present technical concepts and data clearly

🏖️ Benefits

• Competitive salary • Target bonus of 15% • Ongoing stock awards • 100% coverage of medical, dental, and vision premiums for employee and family • Up to 75% of in-network deductibles funded • 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 • Wellness programs • Tuition reimbursement • Inclusive family-forming support • Free on-site parking and gym facilities at the Waltham headquarters