Job
Description
Role & responsibilities: Lead, manage, track, and ensure the timely completion of Quality Management System (QMS)-related documents, Standard Operating Procedures (SOPs), and other departmental paperwork. Ensure the facility operates in full compliance with GMP requirements. Ensure compliance with EHS (Environmental Health & Safety) standards. Lead all aspects of facility operations, including cleanroom maintenance, equipment qualification, and environmental monitoring. Ensure all systems (HVAC, BMS, water systems, etc.) are functioning within validated parameters. Work closely with QA, Validation, and Engineering teams to support new installations, expansions, or requalification efforts. Direct engineering and maintenance teams in preventative and corrective maintenance strategies. Facilitate effective communication between departments to address and resolve facility-related issues promptly. Ensure safety, training, and development of facility staff. Manage contractors, vendors, and service providers involved in facility design, maintenance, and upgrades. Lead site readiness for inspections, audits, and periodic reviews of facility systems. Build and foster a strong GMP and quality culture across the site. Preferred candidate profile Bachelors or Masters degree in Science (Mechanical, Electrical, Chemical, Biomedical) or related technical field. Approx 10 years of experience in facility and engineering management within GMP biopharma or cell therapy facilities. Strong working knowledge of GMP cleanroom requirements, HVAC/BMS/EMS systems, and utility validation. Familiarity with cell and gene therapy/biologics/biopharma manufacturing infrastructure (closed systems, modular cleanrooms, etc.) is a strong plus. Experience managing large teams and multi-disciplinary projects in regulated environments. Hands-on experience with quality systems, including documentation, investigations, and CAPA management. Proficiency in regulatory inspection readiness and hosting (FDA, EMA, local authorities).
