QC Manager

About the role

The QC Manager leads the Microbiology and Chemistry laboratories, ensuring testing activities meet FDA, USP, and cGMP requirements. Working closely with Manufacturing, Supply Chain, Quality, Regulatory, and R&D teams, the role drives compliance, quality, and operational excellence.

Key responsibilities

• Direct and manage all Microbiology and Chemistry laboratory operations.
• Coordinate laboratory activities with Manufacturing and Supply Chain.
• Supervise, train, and develop exempt and non‑exempt laboratory personnel.
• Maintain efficient, cost‑effective laboratory services in compliance with regulations.
• Prepare weekly, monthly and annual reports for site leadership.
• Develop, implement and maintain laboratory SOPs, policies and change‑control processes.
• Conduct investigations, root‑cause analyses and trend analyses including Annual Product Review.
• Oversee the laboratory validation program and support method‑transfer activities.
• Manage the Product Stability Program and support process validation initiatives.
• Lead continuous‑improvement projects within the labs.

Required profile

• Proven experience leading Microbiology and/or Chemistry laboratories in a regulated environment.
• Strong knowledge of FDA regulations, USP standards and current Good Manufacturing Practices (cGMP).
• Demonstrated ability to manage validation, stability and method‑transfer programs.
• Experience with change‑control, root‑cause analysis and trend analysis.
• Effective leadership and people‑development skills.

Required skills

• FDA regulations
• USP standards
• cGMP compliance
• Laboratory validation
• Method transfer
• Change control
• Root cause analysis
• Trend analysis
• Stability testing