Head of Product Quality

Alexion Pharmaceuticals, Inc.; Dublin; On-site; EUR 180,000 - 280,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. seeks a seasoned Product Quality leader to shape and steer Quality across development, regulatory, and commercial supply.

You will ensure every product has a defined Product Quality Leader and embed Quality as a strategic partner in lifecycle decisions. The ideal candidate has 15+ years in Product Quality within biopharma, deep GMP knowledge, and a proven track record influencing regulatory inspections and cross-functional leadership.

Qualifications

• Senior leadership experience in Product Quality within biopharma (15+ years).
• Deep knowledge of EU/US GMP, ICH Q9(R1), Q10 and lifecycle knowledge management.
• Experience across development, clinical-to-commercial transition and launch readiness.
• Credibility with health authorities (FDA, EMA, PMDA) and inspections.

Responsibilities

• Lead the global Product Quality organisation and shape support across development to commercial supply.
• Ensure each product has a Product Quality Leader with clear decision rights.
• Set strategy, operating model, standards and capabilities for Product Quality across stages.
• Maintain inspection readiness and communicate Quality positions to regulators and audits.

Skills

Product quality leadership

Quality strategy

Regulatory liaison

Quality risk mgmt

AI in quality

Education

Pharmacy degree

MBA or advanced degree

Job description

This Is What You Will Do

• Lead the global Product Quality organisation and shape how Quality supports products and clinical programmes from development through commercial supply.
• Ensure each product and programme has one accountable Product Quality partner who brings together specialist expertise and provides a clear, integrated Quality position across the lifecycle.
• Set the strategy, operating model, standards and capabilities for Product Quality across clinical and commercial stages, including the integrated Quality approach for drug–device combination products.
• As a member of the Quality Operations Leadership Team, help deliver our long-term vision for a predictive, trusted and digitally enabled Quality function that identifies risk early and supports the timely delivery of medicines to patients.

You Will Be Responsible For

• Set the Product Quality strategy: Lead the Product Quality strategy and transformation agenda, strengthening accountability and embedding Quality as an active partner in product and programme decisions.
• Manage marketing authorisations, APQR and supply risk: Liaise with Global Regulatory Affairs on Marketing Authorisation approval and maintenance, and oversee the Annual Product Quality Review (APQR) process. Lead the resolution of product-specific Quality risks and issues impacting supply or compliance, including business continuity and supply risk management, on behalf of Quality Operations.
• Build accountable product leadership: Ensure every product and programme has a Product Quality Leader (PQL) or Clinical Product Quality Leader (CPQL) with clear decision rights, escalation points and access to specialist expertise. Align coverage and capacity to portfolio risk, lifecycle needs and strategic priorities.
• Lead Quality across the product lifecycle: Oversee the CPQL model from clinical supply through Regulatory Filings, launch readiness and transfer to commercial supply, and the PQL model for marketed products across internal sites, external partners, suppliers, testing, distribution and markets.
• Provide an integrated Product Quality position: Establish the framework for reaching and communicating one clear Quality position for each product, including drug–device combination products, using Quality Risk Management in line with ICH Q9(R1). Represent that position in senior and executive forums while respecting the formal accountabilities of sites, suppliers, Qualified Persons and Regulatory Affairs.
• Strengthen portfolio oversight and product knowledge: Identify recurring issues across products, sites, suppliers and markets and ensure they are addressed by the appropriate process, site or functional owner. Sponsor lifecycle product knowledge management in line with ICH Q10, keeping control strategies, specifications and commitments current.
• Partner across the organisation: Build effective relationships across Development, Manufacturing, Supply Chain, Regulatory Affairs, Medical Safety and Commercial. Bring Quality into planning early and anticipate launch, change and investigation constraints before they become critical escalations.
• Advance trusted use of AI: Use AI to improve product-risk assessment and identify emerging Quality signals across the portfolio. Ensure AI-supported recommendations are transparent and have a named, authorised human decision-maker, working with Quality Systems and Quality Data, Digital & AI Assurance.
• Maintain inspection readiness: Ensure product decisions and records are inspection‑ready and aligned with ALCOA+ data‑integrity principles. Represent Product Quality strategy, governance and decision rationale to health authorities and auditors.
• Lead the organisation and its performance: Maintain a portfolio view of product risk, decision effectiveness, stakeholder experience and lifecycle readiness. Own the Product Quality budget, resources and capability plan, and build leadership capability and succession across the organisation.

You Will Need To Have

• A degree in pharmacy, science, engineering or a related discipline.
• Extensive senior leadership experience in Product Quality, CMC Quality or Quality Operations within the biopharmaceutical industry, typically gained over 15 or more years.
• Demonstrated success leading Quality strategy and transformation while maintaining strong operational delivery.
• Deep knowledge of EU and US Good Manufacturing Practice, ICH Q9(R1), ICH Q10 and related guidance, together with strong expertise in product risk, control strategies, specifications, comparability and lifecycle knowledge management.
• Experience across development, clinical‑to‑commercial transition, launch readiness and commercial supply, including internal sites, external partners and contract manufacturers.
• Credibility with health authorities such as the FDA, EMA and PMDA, including experience leading or supporting regulatory inspections and pre‑approval inspections.
• Strong enterprise judgement, with the ability to balance product, patient and supply considerations, influence without direct authority and communicate clear positions to executives.
• Proven ability to build and develop leaders and lead teams across multiple sites and geographies.
• Practical data and AI fluency, including the ability to shape use cases, assess outputs and support appropriate human oversight.
• Excellent written and verbal communication, with the ability to explain complex Quality positions clearly to executives, cross‑functional partners and regulators.

We Would Prefer For You To Have

• An advanced degree such as an MSc, PhD or MBA.such as Pharmacy, Biology, Chemistry; Master’s degree preferred
• Experience providing Quality input to alliance management, business development or due diligence.Typical People Management Responsibility (direct / indirect reports)10-20Education, Qualifications, Skills and Experience
• Extensive experience in multiple areas of quality delivery within a pharmaceutical manufacturing environment.
• Experience in leading and managing a sizeable quality function and delivering improvements.
• Experience having led large-scale change initiatives from planning to implementation.
• Experience working with regulatory / SOP / GxP requirements and driving compliance across teams.
• Experience managing large teams with direct and indirect reports.
• Experience planning and managing budgets and resources for large quality function or a site.

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.