Senior Manager, Quality Assurance GMP

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CultureHQ

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1 - 10 Mitarbeiter

Gegründet 2017

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Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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