Director, GMP Systems

AstraZeneca • Gaithersburg, MD

1d • Onsite

About The Position

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.

Nice To Haves

• Experience building and scaling reliability-centered maintenance programs in regulated biopharmaceutical environments
• Depth in risk tools and methods (FMEA, root cause analysis, risk ranking) to drive prioritization and decision-making
• Proficiency with CMMS, asset management, and maintenance analytics to govern KPIs and performance trends
• Demonstrated strength in cross-functional influence and partnership with Quality, Engineering, and Operations to align validated states and handover criteria
• Track record of inspection readiness leadership, including leading audits and resolving critical observations with durable CAPAs
• Proven vendor and OEM management, contract performance governance, and escalation discipline
• Capability development of managers and leads, succession planning across buildings, and culture building focused on ownership, safety, and continuous improvement

Responsibilities

• 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 preventive actions
• Ensure SHE, GMP, and quality requirements are fully embedded into GMP maintenance planning and execution
• Ensure all FTEs, OSPs, and contractors operate in compliance with GMP, safety, and quality requirements
• Serve as the decision authority and escalation point for cross-building GMP maintenance risks that could impact product quality, patient safety, or manufacturing continuity
• Partner closely with Quality to ensure maintenance practices align with validated states and regulatory expectations
• Drive GMP maintenance planning, execution, and continuous improvement across all GMP buildings
• Partner with Reliability, Metrology, Automation, and Quality teams to ensure integrated GMP system support
• Establish, monitor, and govern KPIs for GMP maintenance performance, reliability, compliance, inspection readiness, and maintenance effectiveness across the campus
• Use data, risk assessments, and performance trends to prioritize risk-based maintenance improvements and resource allocation
• Proactively identify and mitigate risks that could impact product quality, regulatory compliance, or manufacturing continuity
• Partner with Facilities & Engineering, Project Engineering, PMO, Quality, and Operations across the Gaithersburg campus
• Provide formal GMP maintenance input into system design, project planning, and turnover activities, without direct project ownership
• Establish and enforce GMP maintenance readiness criteria for system acceptance and handover
• Conduct or delegate formal GMP maintenance readiness assessments prior to system acceptance
• Escalate and block system handover when GMP maintenance, documentation, or compliance requirements are not met
• Provide direct and matrix leadership to GMP maintenance teams and contractors supporting multiple GMP buildings across the campus
• Ensure technical competency, GMP compliance mindset, and performance excellence across all GMP maintenance organizations
• Develop and align GMP maintenance managers and leads to ensure consistency, depth of coverage, and succession readiness across buildings
• Hold service providers and OEMs accountable through defined KPIs, performance metrics, and compliance expectations
• Foster a culture of ownership, quality, safety leadership, and continuous improvement

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed