Global Head of Product Quality & AI-Enabled Transformation
Alexion Pharma Spain S.L.
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Job summary
Alexion Pharma Spain S.L. is seeking a Head of Product Quality in Blanchardstown, Ireland to lead the global Product Quality organisation from development through commercial supply.
You will set strategy, drive governance, and partner across Regulatory Affairs, Manufacturing, and Supply Chain to ensure quality is embedded in lifecycle decisions. The role requires deep GMP knowledge, 15+ years in quality leadership within biopharma, and strong experience with regulatory inspections and AI-enabled
Qualifications
- Extensive senior leadership experience in Product Quality/Quality Operations within biopharmaceuticals.
- Deep knowledge of EU/US GMP, ICH Q9(R1), ICH Q10 and related guidance.
- Experience spanning development to commercial supply, including regulatory inspections.
Responsibilities
- Set and lead Product Quality strategy and transformation across clinical to commercial stages.
- Oversee Marketing Authorisation maintenance, APQR processes and supply risk management.
- Establish Product Quality Leaders with clear decision rights and escalation points.
- Lead CPQL/PQL models and ensure coverage across sites, partners and suppliers.
- Represent the Product Quality position in senior forums and maintain lifecycle readiness.
Skills
Education
Job description
Alexion Pharma Spain S.L. is seeking a Head of Product Quality in Blanchardstown, Ireland to lead the global Product Quality organisation from development through commercial supply.
You will set strategy, drive governance, and partner across Regulatory Affairs, Manufacturing, and Supply Chain to ensure quality is embedded in lifecycle decisions. The role requires deep GMP knowledge, 15+ years in quality leadership within biopharma, and strong experience with regulatory inspections and AI-enabled
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