Quality Control Laboratory Manager

About the role

The Quality Control Laboratory Manager leads the QC laboratory, ensuring that all testing, validation, and compliance activities meet regulatory and internal standards. This senior position oversees laboratory operations, instrument management, and team development to support product quality and release.

Key responsibilities

• Lead QC activities such as laboratory purchasing, inventory management, and new product introductions for raw and packaging materials.
• Draft and review specifications, standard operating procedures (SOPs), and analytical methods, including method validation protocols and reports.
• Manage instrument qualification, calibration, and lifecycle, coordinating with third‑party vendors and maintaining qualification documentation.
• Ensure compliance with FDA, USP, EP, ICH, and ChP regulations and internal controlled procedures.
• Conduct laboratory investigations, document findings, and initiate change control and CAPEX requests.
• Oversee data integrity, real‑time documentation, and traceability for all QC activities.
• Prepare and support QC budget, training programs, and performance metrics for the laboratory team.
• Maintain audit readiness for internal and external inspections.

Required profile

• Degree in Chemistry, Pharmaceutical Sciences, or a related discipline.
• Extensive experience in a QC laboratory within a regulated environment.
• Proven leadership skills with experience managing a team of analysts.
• Strong understanding of cGMP, FDA, USP, EP, ICH, and ChP requirements.
• Excellent documentation and change‑control practices.

Required skills

• Method validation and verification (MV/MT).
• Instrument qualification, calibration, and lifecycle management (URS, DQ, IOQ, PQ).
• Regulatory compliance (FDA, USP, EP, ICH, ChP).
• SOP development and controlled documentation.
• Data integrity and traceability management.
• CAPEX budgeting and financial planning for laboratory equipment.