You will need to be within a commutable distance from one of our Ireland facilities, Dublin, Killorglin or Tralee.
Head of AICL, QA
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
The AICL QA Head is accountable for establishing and maintaining a robust, compliant, and effective Quality Assurance network across AICL’s three manufacturing sites (Kerry, Dublin, Tralee). This role ensures alignment with global regulatory standards (EU GMP, FDA CFR, etc.) while overseeing all QA operations including audits, documentation control, deviation/CAPA management, validation oversight, and change control.
As a Qualified Person (QP) or an individual with in-depth understanding of QP responsibilities, the incumbent ensures compliant and timely final product release and protects patient safety and regulatory integrity. This position fosters a strong and consistent quality culture across all AICL sites in alignment with Astellas’ global quality strategy.
Key Responsibilities:
Leadership in line with corporate strategy:
- Develop and implement efficient and high-performance site QA operational schemes in line with the corporate strategy.
- Align site QA objectives with global Astellas initiatives, ensuring synergy between production, engineering, regulatory affairs, and global QA functions.
- Lead quality risk management at site leadership level, anticipating regulatory, operational, and market changes.
Multi-Site QA Leadership:
- Directly or indirectly lead and oversee QA activities at Kerry, Dublin, and Tralee sites
- Ensure QMS, audit preparedness, deviation management, CAPA, validation, and change control processes meet all global and regional regulatory requirements.
- Drive alignment of quality standards and practices across sites and cultivate a shared quality culture.
Organization Management & Talent Development:
- Manage and develop the QA leadership team, ensuring competency growth, succession planning, and high engagement.
- Drive performance management processes, setting clear strategic priorities and measuring against agreed KPIs.
Quality Management System (QMS) Oversight:
- Direct the design, implementation, and continuous improvement of the site QMS to meet EU GMP, FDA CFR, and other global standards
- Ensure consistency of QA processes across documentation, change control, validation, and deviations.
Regulatory Compliance & Inspection Readiness:
- Ensure strategic site readiness for inspections by authorities such as HPRA, EMA, FDA.
- Lead site responses to inspection findings, ensuring timely and effective CAPA implementation.
Issue & Risk Management:
- Oversee investigation and resolution of significant quality issues including manufacturing defects, regulatory findings, and customer complaints.
- Escalate critical events globally with full impact assessments.
Cross‑Functional & Global Collaboration:
- Build robust internal and external stakeholder relationships, fostering collaboration across production, engineering, supply chain, and regulatory affairs.
- Represent QA in global forums, sharing best practices and contributing to enterprise‑wide quality improvement programs.
Leadership & Culture Development:
- Mentor QA leaders and staff; promote operational excellence, Lean principles, and a proactive compliance mindset.
Education:
- Bachelor’s degree in a science-related field (Pharmacy, Chemistry, Biology, etc.) or equivalent.
Preferred Skills/ Experience:
- Advanced degree (Master’s or PhD) in relevant scientific discipline.
- Significant experience in pharmaceutical QA, with substantial experience in leadership.
- QP certification or thorough knowledge of QP responsibilities per EU Directive 2001/83/EC.
- Thorough knowledge of EU GMP, FDA CFR, and other global regulatory requirements.
- Strong understanding of manufacturing operations in biologics, solid dose, or parenterals
- Experience managing regulatory inspections across multiple authorities (FDA, EMA, HPRA).
- Excellent communication, influencing, and stakeholder management skills in global environments.
- Experience in sterile manufacture and/or solid dosage production.
- Global regulatory submission and change management experience.
- Proven success in quality transformation projects and embedding quality culture.
- Lean Six Sigma or Continuous Improvement training/certification.
Additional Information:
- Candidates should be based within commuting distance of one of our Ireland sites in Dublin, Killorglin, or Tralee.
- This position requires onsite work.
- This position requires travel to Astellas Ireland facilities and infrequent travel for overseas meetings.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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