Director, GMP Maintenance Systems
Listed on 2026-02-28
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Management
Operations Manager, Healthcare Management
Introduction to role:
Are you ready to set the maintenance standards that keep life-changing medicines flowing without interruption? This role leads the campus in shaping a reliability-driven GMP maintenance function that protects product quality, patient safety, and manufacturing continuity.
You will be the final authority for GMP maintenance standards across multiple buildings, guiding teams and partners through change with clarity and conviction. Can you bring diverse voices together to adopt consistent, risk-based practices that elevate performance while sustaining compliance and readiness?
Accountabilities:Campus-wide GMP Strategy and Governance:
Be responsible for the campus maintenance strategy, governance, and execution across all GMP buildings, ensuring a unified approach that supports uninterrupted operations and regulatory compliance.
Maintenance Standardization:Drive standardization of practices, procedures, documentation, and execution expectations so every facility operates to the same high bar of reliability and quality.
Reliability-Centered Transformation:Lead the transition from reactive work to a risk-based, reliability-driven operating model, building asset health and stability into everyday maintenance.
Regulatory Compliance and Inspection Readiness:Maintain continuous GMP compliance and inspection readiness; lead and support internal, external, and regulatory inspections and audits, serving as the primary customer concern point for inspection findings.
Safety and Quality Governance:Embed SHE, GMP, and quality requirements into planning and execution; act as the decision authority for cross-building maintenance risks that could affect product quality, patient safety, or continuity.
KPI and Performance Management:Establish, monitor, and govern KPIs for performance, reliability, compliance, inspection readiness, and maintenance effectiveness; use trends and risk assessments to prioritize improvements and allocate resources.
Multi-functional Design Influence and Handover Control:Partner with Facilities & Engineering, Project Engineering, PMO, Quality, and Operations to provide formal GMP maintenance input into system design, planning, and turnover; carry out readiness criteria and block handover if requirements are not met.
People and Vendor Leadership:Provide direct and matrix leadership to maintenance teams and contractors; build technical competency, a compliance-first mentality, and performance excellence; hold service providers and OEMs accountable through defined KPIs and expectations.
Essential Skills/Experience:
- Bachelor’s degree in Engineering or a related technical discipline
- 15+ years of progressive GMP maintenance, engineering, or operations leadership experience
- 2–5 years of project management experience
- Strong solid understanding of GMP regulations and inspection readiness expectations
- Confirmed ability to lead across multiple GMP buildings or sophisticated campus environments
- Own campus-wide GMP maintenance strategy, governance, and execution across all GMP buildings
- Serve as the final campus authority for GMP maintenance standards, interpretation, and consistent application
- Provide leadership and guidance to GMP maintenance teams and contractors supporting multiple GMP facilities
- Drive standardization of GMP maintenance practices, procedures, documentation, and execution expectations
- Ensure maintenance strategies support equipment reliability, regulatory compliance, and uninterrupted GMP operations
- Lead the transition from reactive maintenance execution to a risk-based, reliability-driven operating model
- Be accountable for maintaining continuous GMP compliance and inspection readiness across all GMP buildings
- Lead and support internal, external, and regulatory inspections and audits related to GMP maintenance scope
- Ensure maintenance documentation, deviations, CAPAs, change controls, and data integrity practices meet GMP requirements
- Act as the primary customer concern point for GMP maintenance–related inspection findings and critical observations
- Identify systemic compliance trends, recurring issues, and inspection themes across GMP buildings, and drive effective corrective and…
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