AICL QA Head, Full Time, Onsite
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
You must be within commutable distance of one of our Ireland facilities: Dublin, Killorglin or Tralee. This position is fully onsite and requires travel between facilities, with infrequent overseas travel.
Working Hours
Full time, onsite role across AICL’s Ireland facilities.
Purpose & Scope
• The AICL QA Head is accountable for establishing and maintaining a robust, compliant, and effective Quality Assurance network across AICL’s manufacturing sites. This role ensures regulatory alignment, oversees QA systems, and safeguards patient safety and product quality.
Role and Responsibilities
• Develop and implement efficient and high performance site QA operational schemes in line with corporate strategy.
• Align QA objectives with global Astellas initiatives across production, engineering, regulatory affairs, and global QA.
• Lead quality risk management at site leadership level.
• Oversee QA activities across Kerry, Dublin, and Tralee sites.
• Ensure QMS, deviation management, CAPA, validation and change control processes meet regulatory expectations.
• Drive alignment of quality standards and foster a shared quality culture across sites.
• Manage and develop QA leadership teams, ensuring competency growth and succession planning.
• Direct design, implementation, and continuous improvement of the Quality Management System.
• Ensure consistency of QA processes across documentation, validation, deviations and change controls.
• Ensure strategic site readiness for inspections (HPRA, EMA, FDA).
• Lead responses to regulatory findings, ensuring timely CAPA implementation.
• Oversee investigation and resolution of major quality issues and escalate critical events.
• Build internal and external stakeholder relationships across production, engineering, supply chain and regulatory affairs.
• Represent QA in global forums to influence enterprise wide quality improvements.
• Mentor QA staff, promoting operational excellence, Lean principles and proactive compliance.
Required Qualifications
• Bachelor’s degree in a science related field (Pharmacy, Chemistry, Biology, etc.) or equivalent.
Preferred Qualifications
• Advanced degree (Master’s or PhD) in a relevant scientific discipline.
• Significant pharmaceutical QA leadership experience.
• QP certification or deep knowledge of QP responsibilities (EU Directive 2001/83/EC).
• Expert knowledge of EU GMP, FDA CFR and global regulatory requirements.
• Strong understanding of biologics, solid dose or parenteral manufacturing.
• Experience managing inspections across multiple authorities (FDA, EMA, HPRA).
• Excellent communication, influencing and stakeholder management skills.
• Experience in sterile manufacture and/or solid dosage.
• Experience with global regulatory submissions and change management.
• Proven success leading quality transformation and embedding a strong quality culture.
• Lean Six Sigma or Continuous Improvement training/certification.
What awaits you at Astellas?
• Global collaboration: Work within a connected global community dedicated to improving patient lives.
• Real world patient impact: Contribute to life changing therapies that help people worldwide.
• Relentless innovation: Be part of an organisation pushing scientific and operational boundaries.
• A Culture of Growth: Thrive in a supportive workplace that values development and progression.
Our Organisational Values and Behaviours
• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus
Benefits
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.
Beware of recruitment scams impersonating Astellas recruiters. Authentic communication will only originate from verified company email addresses or official LinkedIn profiles.
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