Global Head of Quality & Smart Release (QMS)

Alexion Pharma Spain S.L.; Blanchardstown; Remote; EUR 150,000 - 210,000; Full time

Job summary

Alexion Pharma Spain S.L. is seeking a Head of Quality Management Systems & Smart Release in Blanchardstown, Dublin.

You will own the global QMS and drive the Smart Release program, coordinating CAPA, deviation handling, change control, and training governance across the Rare Disease Unit. The role requires extensive global quality leadership in a regulated biopharmaceutical environment, with a focus on AI-enabled data gathering, evidence, and risk-based decision making.

Qualifications

• Degree in pharmacy, science, engineering or related field.
• Extensive senior Quality leadership in global biopharmaceutical setting.
• Experience with global QMS, complaints, risk management, CAPA, change control and data integrity.

Responsibilities

• Lead Smart Release vision and roadmap, align with Quality Ops needs.
• Own global QMS for Rare Disease Unit; ensure harmonised processes.
• Lead audits and inspections; track benefits like release cycle time and right-first-time.
• Develop and grow a capable global Quality Systems team with AI-enabled capabilities.

Skills

Quality leadership

Cross-functional leadership

AI fluency

Regulatory compliance

Data integrity

Education

Degree in pharmacy/science/engineering

Advanced degree preferred

Tools

SAP Quality

CAPA system

QMS software

Job description

Alexion Pharma Spain S.L. is seeking a Head of Quality Management Systems & Smart Release in Blanchardstown, Dublin.

You will own the global QMS and drive the Smart Release program, coordinating CAPA, deviation handling, change control, and training governance across the Rare Disease Unit. The role requires extensive global quality leadership in a regulated biopharmaceutical environment, with a focus on AI-enabled data gathering, evidence, and risk-based decision making.