Global Product Quality Leader & Strategy

Alexion; Blanchardstown; On-site; EUR 180,000 - 240,000; Full time

Job summary

Alexion, part of AstraZeneca, seeks a senior leader to head Global Product Quality across development and commercial supply. You will shape strategy, lifecycle governance, and accountability for Product Quality partners with clear decision rights.

Lead cross-functional collaboration with Regulatory, Manufacturing and Medical Safety. Drive AI-enabled risk insights while ensuring inspection readiness and regulator liaison.

Qualifications

• Degree in pharmacy, science, engineering or related discipline.
• Senior leadership experience in Product Quality or Quality Operations (15+ years).
• Proven success leading Quality strategy and transformation.
• Strong EU/US GMP and ICH Q9(Q1)/Q10 knowledge.
• Experience across development to commercial supply, with internal and external partners.

Responsibilities

• Lead the global Product Quality organisation and shape Quality support from development to commercial supply.
• Ensure each product has a Product Quality Leader with clear decision rights.
• Set strategy, standards and capabilities for Product Quality across lifecycle.
• Lead Quality across product lifecycle, including regulatory filings and transfer to supply.
• Establish an integrated Quality position for drug-device combinations and communicate with authorities.
• Strengthen portfolio oversight, sponsor knowledge management, and control strategies.
• Partner across Development, Manufacturing, Regulatory Affairs, Medical Safety and Commercial.
• Advance AI use for risk assessment with transparent, human-reviewed recommendations.
• Maintain inspection-ready records and represent Quality strategy to regulators.

Skills

Product Quality leadership

CMC Quality

Regulatory knowledge

Quality risk management

AI fluency

Cross-functional leadership

Executive communication

Education

Degree in pharmacy, science, or engineering

Tools

APQR process

Regulatory inspections

ICH Q9/Q10 knowledge

Job description

Alexion, part of AstraZeneca, seeks a senior leader to head Global Product Quality across development and commercial supply. You will shape strategy, lifecycle governance, and accountability for Product Quality partners with clear decision rights.

Lead cross-functional collaboration with Regulatory, Manufacturing and Medical Safety. Drive AI-enabled risk insights while ensuring inspection readiness and regulator liaison.