Senior Quality Control Manager

• Manage and develop the Quality Control team, including setting goals, assigning responsibilities, mentoring staff, and conducting performance reviews.
• Oversee day-to-day QC operations including scheduling, resource planning, and prioritization of testing and data review activities.
• Provide hands-on guidance and technical direction to analysts and scientists for method troubleshooting, investigations, and laboratory best practices.
• Ensure all internal QC operations comply, as needed, with GMP, GLP, ICH, USP/EP, and FDA/EMA regulations.

• Serve as the primary QC liaison for external partners (CDMOs, CROs, contract labs), ensuring alignment on analytical requirements, timelines, and quality standards.
• Review and approve analytical packages, protocols, and reports generated by third parties to ensure regulatory compliance and data integrity.
• Collaborate closely with QA, Regulatory Affairs, Manufacturing, R&D, and Analytical Development to align testing strategy with broader product development goals. Review and approve CDMO and internal R&D data packages and provide to QA. 

• Lead and/or approve the development, optimization, transfer, and validation of analytical methods in alignment with ICH Q2(R2) and Q14.
• Oversee complex investigations (e.g., OOS, OOT), including root cause analysis and CAPA execution, with a focus on timely resolution and continuous improvement.
• Ensure data integrity and compliance with ALCOA+ principles across applicable testing workflows.
• Support regulatory filings by ensuring the accuracy and completeness of analytical documentation and validation data.
• Create processes to manage tech transfer and method verification/validation including trouble shooting and development improvements as needed.
• Review laboratory documents, data, and analytical packages
• Author SOPs, protocols, test methods, reports, and batch records.

• Maintain oversight of electronic systems (e.g., LIMS, Empower, ELNs), ensuring data traceability, access control, and system validation as needed.
• Author, review, and approve SOPs, protocols, reports, and other quality documents associated with laboratory operations.
• Participate in internal and external audits and regulatory inspections, serving as the QC subject matter expert
• Monitor and trend QC metrics (e.g., deviations, method performance, lab compliance) and lead improvement initiatives based on data analysis and Key Process Indicators (KPIs).

• Develop and execute QC strategies that align with product lifecycle needs and Antheia’s quality objectives.
• Provide consultation on quality and compliance topics in areas of expertise and assist with quality control improvement initiatives.
• Support budgeting, capital planning as needed.
• Contribute to the selection and qualification of analytical laboratories and vendors.

• Perform other duties as assigned^[1]

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.

[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.