Senior Quality Control Manager

Responsibilities

• Team & Operational Leadership
• 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.
• External & Cross-Functional Leadership
• 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.
• Technical Oversight
• 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.
• Quality Systems & Compliance
• 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).
• Strategic & Organizational Contribution
• Develop and

Benefits

Additional Information

About Antheia: Antheia is the advanced biosynthesis company transforming pharmaceutical manufacturing and innovation for the 21st century. Antheia's commercially proven technology platform produces high-value pharmaceutical ingredients in a fraction of the time compared to legacy approaches while significantly reducing supply chain risk. The company provides its global pharmaceutical customers with a resilient, efficient supply of critical ingredients at scale, while expanding the innovation frontier for new therapeutic development. Backed by leading investors and recognized by the U.S. government as a priority technology for public health and national and economic security, Antheia is manufacturing the medicines the world needs today while enabling tomorrow's breakthrough therapeutics. Working at Antheia: Our cross-functional team shares a vision for the future: improved pharmaceutical supply chains that can end drug shortages and drive equitable access to essential medicines. As a team, we aim to embody a culture that celebrates diversity, prioritizes knowledge sharing, encourages exploration and ideation, challenges constructively, and supports individuals in their professional and personal journeys. At Antheia, you can expect to be inspired by the science, by your teammates, and by the opportunity we have to bring about change in the pharmaceutical industry. The Senior Quality Control (QC) Manager is responsible for leading Antheia's Quality Control function across GMP and non-GMP environments, spanning from R&D through scale-up to commercial pharmaceutical manufacturing. This position combines technical expertise in analytical chemistry with strategic leadership in lab operations, quality oversight, and external partner management. The QC Manager ensures that Antheia's testing programs meet global regulatory expectations and internal standards for scientific rigor, data integrity, and continuous improvement. This role manages a team of QC Analysts and Specialists while providing technical leadership for method development verification, validation, and analytical lifecycle management. The QC Manager also serves as the primary interface between internal teams and third-party testing partners (CDMOs, CROs, Contract Labs), overseeing the quality and timeliness of deliverables and driving resolution of analytical issues.

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