Senior Quality Control Manager

• Lead and develop a team of QC Analysts and Specialists: hiring, mentoring, performance, day-to-day priorities
• Build and improve lab operations infrastructure (scheduling, resource planning, data review workflows)
• Ensure compliance with GMP, ICH, USP/EP, and FDA/EMA standards across all applicable testing

• Serve as the primary QC point of contact for CDMOs, CROs, and contract testing labs
• Review and approve analytical packages, protocols, and reports from third parties for regulatory compliance and data integrity
• Drive resolution when external partners hit analytical issues or timeline delays

• Lead method development, transfer, and validation aligned with ICH Q2(R2) and Q14
• Own complex investigations (OOS, OOT) through root cause analysis and CAPA, with a bias toward speed and continuous improvement
• Ensure data integrity across workflows (ALCOA+ principles, LIMS, Empower, ELNs)

• • Develop QC strategies that align with product lifecycle and multi-site growth
  • Contribute to vendor selection, lab qualification, and capital planning
  • Support regulatory filings with accurate, complete analytical documentation

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biology, or related field. Advanced degree preferred.
• 10+ years of progressive experience in pharmaceutical QC under GMP regulations, with 5+ years in a leadership or managerial role.
• Demonstrated experience managing QC laboratories, supervising analytical staff, and coordinating external testing activities.
• Deep knowledge of chromatographic (HPLC, GC), spectroscopic (UV/Vis, FTIR), and wet chemistry techniques; bioanalytical familiarity is a plus.

• Strong background in method development, validation, and lifecycle management (ICH Q2, Q14).
• Solid experience in OOS/OOT investigations, deviation handling, and CAPA implementation.
• In-depth understanding of FDA, EMA, and ICH regulatory expectations; prior audit experience highly desirable.
• Familiarity with laboratory systems such as LIMS, Empower, and ELNs.
• Excellent written and verbal communication skills with ability to lead cross-functional teams and interface with regulatory agencies and partners.

• Base salary: $160,000 – $195,000 + annual bonus + equity in a high-growth company

[1] This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.

Please note that Antheia doesn't discriminate based on age, race, ethnicity, national origin, religion, gender, sexual orientation, disability, medical history, and other non-merit characteristics.