Senior Manager Quality Control

Job Responsibilities

• Maintain and oversee the Quality Management System in laboratories, including execution of investigations into laboratory errors and quality issues, determination of root causes, and implementation of appropriate CAPAs.
• Monitor laboratory events (LIR and OOS) and ensure compliance with relevant KPIs including cycle time optimisation, reduction in laboratory incidents, and minimisation of out-of-specification results due to laboratory error.
• Manage the change control process for laboratory operations, ensuring all modifications are governed through the appropriate CCM procedure and aligned with current pharmacopeial and regulatory requirements.
• Oversee qualification, calibration, and maintenance of laboratory instruments, minimising downtime whilst maintaining comprehensive documentation and records.
• Manage laboratory licensing, vendor agreements, and quality agreements to ensure effective operational partnerships and compliance.
• Supervise wet chemistry, stability, and microbiology teams to support timely analysis of finished products, intermediates, and raw materials whilst meeting site KPIs and business expectations.
• Conduct audit management activities, respond to audit observations and customer queries, and track compliance report completion for internal and external audits.
• Develop and deliver training programmes to ensure laboratory personnel are adequately qualified for their roles, maintain training records, and identify overdue or periodic training requirements.
• Promote a quality culture within the laboratory, establish data integrity awareness, and implement appropriate controls to prevent data integrity issues.
• Ensure compliance with local and global EHS KPIs, conduct safety-related GEMBA walks, and maintain availability of trained emergency response and first aid personnel across all shifts.

Function: Other
Experience Level: Mid-Senior Level