Senior Manager, Maintenance & Calibration Operations
About The Position
The Senior Program Manager, Maintenance & Calibration reports to the Associate Director, GMP Maintenance and Calibrations and is accountable for the leadership and continuous improvement of site GMP maintenance and calibration programs in compliance with cGMP and regulatory requirements. The role serves as the primary maintenance and calibration interface for capital projects and provides oversight of planning and scheduling, budget and service contract management, MRO Parts, and QC Equipment Management, ensuring all associated quality systems, procedures, and investigations comply with site and regulatory standards.
Requirements
- Demonstrated experience managing GMP maintenance and calibration programs in a regulated manufacturing environment.
- Strong knowledge of cGMP requirements, quality systems, and regulatory expectations.
- Experience supporting capital projects and interfacing with cross‑functional engineering teams.
- Proven ability to manage budgets, service contracts, and vendor performance.
- Strong leadership, communication, and organizational skills.
Nice To Haves
- Experience managing maintenance and calibration teams in a pharmaceutical or biotech environment.
- Experience driving business process improvements in maintenance, calibration, or engineering functions.
- Experienced in Regulatory Agency audits.
Responsibilities
- Lead continuous improvement of the GMP Maintenance and Calibration programs for California Facilities and Engineering.
- Serve as the Maintenance & Calibration representative on CAP/Opex projects across all phases of the project lifecycle.
- Manage maintenance and calibration planning and scheduling team to ensure timely and compliant execution of work.
- Manage QC Equipment Management team and associated calibration activities.
- Manage the MRO Parts group
- Review and manage departmental budgets, including forecasting, purchase orders, reconciling review, and cost allocation strategies.
- Ensure completion and documentation of quality investigations, deviations/CAPAs, and change controls related to maintenance and calibration.
- Establish, review, and manage service contracts in collaboration with Legal and Procurement.
- Ensure all maintenance and calibration activities are executed in accordance with cGMP regulations, safety standards, and site quality systems.
- Representative for Facilities departments in a regulatory audit where required
- Participate in design and technical reviews from a maintenance, calibration, and lifecycle management perspective.
- Perform other duties as assigned in support of Facilities and Engineering objectives.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
501-1,000 employees
