Global Head of Quality Management Systems & Smart Release

AstraZeneca plc; Dublin, Athlone, Cork; Remote; EUR 150,000 - 190,000; Full time

Job summary

AstraZeneca plc is seeking a senior Quality Operations leader to own the global QMS and oversee complaints, CAPA, change control, documentation and training within the Rare Disease Unit. You will align processes across Dublin, Athlone and Cork sites, driving simplification, governance and AI-enabled review.

You will champion quality risk management, lead inspections, and develop a capable, inspection-ready global team, delivering measurable benefits in cycle time, right-first-time and release

Qualifications

• Extensive senior Quality leadership in a global, highly regulated biopharmaceutical setting.
• Proven leadership of global Quality Systems and Complaints, including regulatory inspections.
• Experience in AI-enabled quality programs and risk-based review.

Responsibilities

• Own the global QMS for the Rare Disease Unit and its core processes.
• Lead the Digital QMS programme and harmonise processes across sites.
• Drive AI-enabled evidence gathering and risk-based decision making.
• Prepare inspection-ready global team and support audits.

Job description

AstraZeneca plc is seeking a senior Quality Operations leader to own the global QMS and oversee complaints, CAPA, change control, documentation and training within the Rare Disease Unit. You will align processes across Dublin, Athlone and Cork sites, driving simplification, governance and AI-enabled review.

You will champion quality risk management, lead inspections, and develop a capable, inspection-ready global team, delivering measurable benefits in cycle time, right-first-time and release