Director, GMP Systems

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:

• 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 maintenancerelated 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

Desirable Skills/Experience:

• 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

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -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 doesnt mean were 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 $141751 to $ positions offer eligibility for various incentivesan 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.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.