Alexion

Global biopharmaceuticals focusing on rare diseases

Senior Director - Head of Product Quality

Regulatory & Quality (Life Sciences)Updated on Nov 14

Full-timeDublin, IrelandNo salary listedIn-person

About the Job

Requirements

A degree in pharmacy, science, engineering, or a related discipline is required.
Extensive senior leadership experience in Product Quality, CMC Quality, or Quality Operations within the biopharmaceutical industry, typically gained over 15 or more years, is required.
Demonstrated success leading Quality strategy and transformation while maintaining strong operational delivery is required.
Deep knowledge of EU and US Good Manufacturing Practice, ICH Q9(R1), ICH Q10, and related guidance is required, 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, is required.
Credibility with health authorities such as the FDA, EMA, and PMDA, including experience leading or supporting regulatory inspections and pre-approval inspections, is required.
Enterprise judgment to balance product, patient, and supply considerations, influence without direct authority, and communicate clear positions to executives is required.
Proven ability to build and develop leaders and lead teams across multiple sites and geographies is required.
Practical data and AI fluency, including the ability to shape use cases, assess outputs, and support appropriate human oversight, is required.
Written and verbal communication ability to explain complex Quality positions clearly to executives, cross-functional partners, and regulators is required.
Extensive experience in multiple areas of quality delivery within a pharmaceutical manufacturing environment is required.
Experience leading and managing a sizeable quality function and delivering improvements is required.
Experience leading large-scale change initiatives from planning to implementation is required.
Experience working with regulatory, SOP, and GxP requirements and driving compliance across teams is required.
Experience managing large teams with direct and indirect reports is required.
Experience planning and managing budgets and resources for a large quality function or site is required.

Responsibilities

Lead the global Product Quality organization and shape how Quality supports products and clinical programs from development through commercial supply.
Ensure each product and program 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 the long-term vision for a predictive, trusted, digitally enabled Quality function that identifies risk early and supports timely delivery of medicines to patients.
Lead the Product Quality strategy and transformation agenda, strengthening accountability and embedding Quality as an active partner in product and program decisions.
Liaise with Global Regulatory Affairs on Marketing Authorisation approval and maintenance, oversee the Annual Product Quality Review process, and lead resolution of product-specific Quality risks and issues affecting supply or compliance, including business continuity and supply risk management, on behalf of Quality Operations.
Ensure every product and program has a Product Quality Leader or Clinical Product Quality Leader with clear decision rights, escalation points, and access to specialist expertise; align coverage and capacity to portfolio risk, lifecycle needs, and strategic priorities.
Oversee the Clinical Product Quality Leader model from clinical supply through regulatory filings, launch readiness, and transfer to commercial supply, and the Product Quality Leader model for marketed products across internal sites, external partners, suppliers, testing, distribution, and markets.
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 the Quality position in senior and executive forums while respecting the formal accountabilities of sites, suppliers, Qualified Persons, and Regulatory Affairs.
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.
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.
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.
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.
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 organization.

Desired Qualifications

An advanced degree such as an MSc, PhD, or MBA, such as in Pharmacy, Biology, or Chemistry; a Master's degree is preferred.
Experience providing Quality input to alliance management, business development, or due diligence is preferred.

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)
10-20

Education, 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.

Date Posted

13-Nov-2026

Closing Date

30-Dec-2026Our 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.

About the Company

Alexion

Global biopharmaceuticals focusing on rare diseases

Alexion, now the rare disease group within AstraZeneca, develops and sells therapies for rare and ultra-rare diseases by targeting the complement immune system. Its drugs, such as Soliris and Ultomiris, inhibit the C5 component to slow or stop disease processes, while Strensiq and Kanuma address specific metabolic disorders. It differentiates itself through a deep focus on complement biology, pursuing first- or best-in-class therapies, and using a strategy that blends internal R&D with acquisitions to expand its pipeline. Its goal is to improve outcomes for patients with rare diseases and bring these therapies to a broader international market using AstraZeneca’s scale and capabilities.

Company size: 5,001-10,000
Company stage: IPO
Headquarters: Boston, MA
Founded: 1992

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