Global Head of Product Quality & Strategy

AstraZeneca plc; Dublin; Vor Ort; EUR 180.000 - 240.000; Vollzeit

Zusammenfassung

AstraZeneca plc is seeking a senior leader to head the global Product Quality organisation, shaping how Quality supports products from development through commercial supply. You will ensure each product has an accountable Product Quality Leader and drive the strategy, standards, and capabilities across lifecycle.

Role requires deep EU/US GMP knowledge, 15+ years in Quality Operations, and strong stakeholder engagement with regulators.

Qualifikationen

• Degree in pharmacy, science, engineering or related discipline.
• Extensive senior leadership experience in Product Quality, CMC Quality or Quality Operations, typically 15+ years.
• Proven success leading Quality strategy and transformation with strong operational delivery.
• Deep knowledge of EU/US GMP, ICH Q9(R1), ICH Q10 and related guidance; expertise in risk, control strategies, specs and lifecycle management.
• Experience across development to commercialization, including internal sites, partners and contract manufacturers.
• Credibility with health authorities (FDA, EMA, PMDA) and regulatory inspections.

Aufgaben

• Set the Product Quality strategy and transformation agenda with clear accountability.
• Manage regulatory affairs liaison on MA approvals and APQR processes; lead risk mitigation for supply/compliance.
• Build accountable product leadership with defined decision rights and capacity alignment.
• Oversee CPQL model from clinical supply to regulatory filings and transfer to commercial supply.
• Establish one clear Quality position for each product, communicating with regulators and auditors.
• Sponsor lifecycle product knowledge management, keeping control strategies and commitments current.

Kenntnisse

Strategic leadership

Quality governance

Regulatory awareness

Risk management

Executive communication

AI fluency

Ausbildung

Pharmacy degree

Science/Engineering degree

MSc/PhD/MBA preferred

Jobbeschreibung

AstraZeneca plc is seeking a senior leader to head the global Product Quality organisation, shaping how Quality supports products from development through commercial supply. You will ensure each product has an accountable Product Quality Leader and drive the strategy, standards, and capabilities across lifecycle.

Role requires deep EU/US GMP knowledge, 15+ years in Quality Operations, and strong stakeholder engagement with regulators.