Key Responsibilities:
- Manage and track Quality Management System (QMS)-related documents, SOPs, and departmental paperwork.
- Ensure GMP and EHS (Environmental Health & Safety) compliance across the facility.
- Oversee cleanroom operations, equipment qualification, HVAC/BMS/EMS systems, and utility validation.
- Collaborate with QA, Validation, and Engineering teams for facility expansion, installations, and requalification efforts.
- Direct engineering and maintenance teams for preventive and corrective maintenance strategies.
- Manage contractors, vendors, and service providers involved in facility design and upgrades.
- Lead audit readiness for regulatory inspections (FDA, EMA, local authorities).
- Foster a strong quality culture and drive continuous improvement.
Qualifications:
- Bachelor’s or Master’s degree in Science (Mechanical, Electrical, Chemical, Biomedical) or a related technical field.
- 10+ years of experience in facility and engineering management within GMP biopharma or cell therapy facilities.
Desired Skills:
- Strong knowledge of cleanroom requirements, HVAC/BMS/EMS systems, and utility validation.
- Experience in cell and gene therapy/biologics manufacturing infrastructure.
- Hands-on expertise in quality systems, investigations, and CAPA management.
- Proven ability to manage large teams and multi-disciplinary projects.
- Proficiency in inspection readiness for regulatory audits (FDA, EMA, local authorities).
- Availability for off-hours emergency response and system support.