GMP Compliance Lead

Role Overview

Join us at our Dublin location to lead and cultivate a strong GMP (Good Manufacturing Practices) culture that ensures the safe delivery of critical medications for patients with rare and serious illnesses. In this leadership role, you will guide teams in enhancing quality culture, inspection readiness, and meticulous execution that supports a reliable supply chain.

Key Responsibilities

• Champion GMP leadership by setting clear expectations and embodying a proactive quality culture across operational and support teams.
• Develop and implement advanced GMP training programs focusing on risk and competency-based methods, and assess their effectiveness to promote consistent compliant behaviors.
• Establish and maintain effective contamination control procedures and sustainable behavioral standards.
• Analyze data trends and provide coaching to reduce human error and ensure accuracy in operational performance.
• Enforce documentation compliance, ensuring precise record keeping aligned with regulatory and internal quality standards.
• Strengthen adherence to Quality Management System (QMS) standards, while seeking opportunities to simplify and improve processes.
• Maintain ongoing inspection preparedness through visible quality leadership and reinforcement of standards.
• Identify compliance risks utilizing operational insights and data to prioritize continuous improvements.
• Lead or contribute to change management initiatives impacting GMP practices, quality systems, and organizational behaviors.
• Support the adoption of digital and AI tools to enhance compliance, training, and operational capabilities.
• Coach management and teams to foster ownership and accountability for quality and GMP standards.
• Collaborate across Quality, Manufacturing, Technical, Supply, Training, and Digital departments to achieve cohesive and sustainable results.
• Stay informed on relevant regulatory requirements pertaining to GMP, data integrity, and contamination control and translate them into everyday practices.

Essential Qualifications and Experience

• Extensive experience in GMP-regulated environments, preferably pharmaceutical or biopharmaceutical manufacturing.
• In-depth knowledge of GMP regulations and operational application.
• Expertise in GMP training program design, delivery, and evaluation.
• Strong understanding of contamination control principles and their practical use.
• Proven experience in data integrity management and compliant documentation practices.
• Competence in reinforcing QMS discipline and process adherence.
• Demonstrated leadership and coaching skills to elevate compliance culture.
• Experience leading cultural and operational improvements through change management.
• Familiarity with digital technologies and AI-enabled solutions supporting quality, training, or operational functions.
• Excellent communication, facilitation, stakeholder management, and interpersonal capabilities.
• Ability to engage effectively across various organizational levels and functions.
• Degree or equivalent qualification in scientific, engineering, quality, or related fields with substantial GMP background.

Desirable Experience

• Background in aseptic processing or tightly controlled cleanroom manufacturing environments.
• Knowledge of continuous improvement methodologies, change management, and digital quality or training systems is an advantage.

Why Work With Us

At AstraZeneca and Alexion, we challenge ourselves to uphold the highest standards, driven by our commitment to patients dependent on our medicines. You will collaborate with colleagues who blend scientific precision with innovative problem-solving to foster bold ideas and inclusive teamwork. We prioritize kindness and back initiatives that integrate quality principles with emerging technologies in daily operations. Your leadership will directly impact the consistent supply of vital medicines, positively influencing patients, teams, and communities.

Additional Information

This role fosters an inclusive, equitable workplace where every applicant is valued. We are committed to providing adjustments or accommodations during the recruitment process to enable your best performance; please specify any needs when applying.

Important Dates

• Posted on: 10-Jul-2026
• Application deadline: 19-Jul-2026