Director, GMP Systems

AstraZeneca•Gaithersburg, MD

1d•Onsite

About The Position

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. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. We workfive days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. The annual base pay (or hourly rate of compensation) for this position ranges from $141,751 to $212,627. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Why AstraZeneca: Here, bold ideas become real-world improvements for patients through the power of diverse teams working side by side. You will help shape site practices that blend cutting-edge technology, Lean ways of working, and a reliability-first mindset, all in service of safer, faster, and more sustainable operations. We value kindness alongside ambition and empower people to lead change, from reducing waste and elevating quality to our commitment to eliminate operational emissions by 2025. Join a collaborative environment where your judgment and influence directly impact the medicines patients depend on. Call to Action: If you are ready to set the campus standard for GMP maintenance and lead the shift to reliability-driven performance, step forward and shape the future of our site and the patients it serves.

Requirements

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

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

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