Quality Engineering Manager

This role provides independent Quality oversight and governance of engineering, manufacturing, and technical support activities. This role ensures that outputs generated by Operations, Facilities & Engineering, and MSAT meet cGMP, regulatory, and internal quality standards. The position is responsible for the review and approval of QMS records, investigations, protocols, technical reports, and system deliverables.

The Manager plays a key role in maintaining a robust Quality Management System (QMS) and ensuring inspection readiness, supporting the reliable supply of high-quality sterile injectable and combination products.

• Provide leadership, direction, and support to the people within Quality Engineering and other departments to ensure that they are qualified to achieve a high level of competence, are motivated, and carry out their duties in a safe manner.
• Establish and maintain the site’s quality system processes related to GMP compliance of the facility, equipment, computer systems and manufacturing processes by working across functions.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality-related matters are provided to the site.
• Provide Quality oversight for documentation supporting combination product and device-related activities. Ensure compliance with applicable regulatory expectations (e.g., 21 CFR Part 4 where applicable).
• Review and approve transfer-related documentation to ensure completeness, traceability, and compliance. Ensure alignment between sending and receiving site documentation.
• Oversee and approve maintenance records, calibration records, and system outputs for compliance and data integrity within the Computerized Maintenance Management System (CMMS).