GMP Compliance Lead

Introduction to role:

Are you ready to embed a robust GMP culture that keeps life-changing medicines moving safely to patients? Based at our Dublin site, you will lead the charge on quality culture, inspection readiness, and the disciplined execution that underpins reliable supply for people with rare and devastating diseases.

In this role, you will shape how teams learn, perform, and continuously improve—from contamination control and data integrity to the practical use of our Quality Management System. You will coach leaders and frontline teams to Right First Time performance, reduce human error through insight and coaching, and help us translate complex standards into confident daily practice. Do you see yourself guiding cross-functional teams through change while introducing digital and AI-enabled tools that make training and compliance smarter and more impactful?

Accountabilities:

• GMP Leadership: Set expectations and lead by example to build a visible, proactive culture of GMP and quality across operations and support functions.
• Training Excellence: Design, deliver, and evolve GMP training toward risk-based and competency-based approaches; measure effectiveness and drive consistent behaviours.
• Contamination Control: Embed practical contamination control practices; clarify controls and expectations; sustain the right behaviours over time.
• Human Performance and Right First Time: Use data trends and performance coaching to reduce human error and strengthen capability at the point of execution.
• Data Integrity Stewardship: Champion compliant documentation, accurate record keeping, and disciplined execution aligned with regulatory and internal standards.
• QMS Discipline and Simplification: Reinforce adherence to procedures and standards; identify opportunities for simplification, harmonisation, and continuous improvement.
• Inspection Readiness: Maintain a state of readiness through strong compliance practices, visible quality leadership, and ongoing reinforcement of standards.
• Risk Sensing and Improvement: Identify compliance risks, trends, and opportunities using data and operational insight; prioritise and deliver continuous improvement.
• Change Leadership: Lead or support change initiatives affecting GMP practices, quality systems, training approaches, and organisational behaviours using structured change management.
• Digital and AI Enablement: Contribute to practical, efficient digital and AI-enabled solutions that elevate compliance, learning, and capability building.
• Coaching and Ownership: Coach and support managers and teams to strengthen accountability, engagement, and ownership for GMP and quality standards.
• Cross-Functional Collaboration: Partner with Quality, Manufacturing, Technical, Supply, Training, and Digital teams to deliver aligned and sustainable outcomes.
• Regulatory Vigilance: Maintain current knowledge of applicable GMP, data integrity, and contamination control expectations and translate them into day-to-day practice.

Essential Skills/Experience:

• Significant experience working in a GMP-regulated environment, preferably within pharmaceutical, biopharmaceutical, or other regulated manufacturing settings.
• Strong working knowledge of GMP requirements and their practical application in an operational environment.
• Experience in GMP training, including designing, delivering, facilitating, or improving training programmes and learning interventions.
• Sound understanding of contamination control principles and their practical implementation.
• Good knowledge of data integrity requirements and demonstrated experience in promoting compliant documentation and record management practices.
• Experience in promoting and reinforcing QMS adherence and procedural discipline.
• Demonstrated ability to lead, coach, and influence others to strengthen compliance behaviours and build a positive GMP culture.
• Evidence of contributing to or leading cultural change, operational improvement, or business transformation initiatives.
• Experience applying change management principles to support adoption and sustain improvements.
• Awareness of AI and digital technologies, with some practical experience of digital tools, systems, analytics, automation, or AI-enabled solutions in a business, operational, quality, or training context.
• Strong communication, facilitation, stakeholder engagement, and interpersonal skills.
• Ability to work effectively across functions and at multiple levels of the organization.
• Degree or equivalent experience in a scientific, engineering, quality, or related discipline along with substantial experience working in a regulated GMP environment.

Desirable Skills/Experience:

• Experience in aseptic processing, cleanroom operations, or other tightly controlled manufacturing settings would be advantageous.
• Familiarity with change management, continuous improvement, and digital systems used in quality or training environments will be highly valued.

Why AstraZeneca:Join a company where the bar is high because patients count on us—especially those living with rare and devastating diseases. You will work with colleagues who combine scientific rigor with practical ingenuity, often bringing unexpected teams into the same room to unlock bold thinking. We value kindness alongside ambition, and we back ideas that turn quality principles into daily practice through modern technology and close collaboration. Your expertise will directly influence how reliably we supply medicines, connecting your leadership to outcomes that matter for patients, teams, and the communities we serve.

Call to Action:If you are ready to build a lasting GMP legacy in Dublin that strengthens quality, accelerates supply, and makes a measurable difference for patients, take the next step today!

Date Posted

26-Jun-2026

Closing Date

09-Jul-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.