Quality Assurance Operations
Confirmed on the employer's own hiring board on Oct 18, 2026. First seen by Alion on Oct 8, 2026.
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.
Working Environment and Location
- This position is based in Tralee, Ireland.
- This position requires you to be 100% on site / in the office.
Purpose and Scope
The Quality Assurance Operations role will be primarily responsible for ensuring compliance of all manufacturing activities that form part of the Astellas Ireland Tralee Plant operations. Responsibilities will include establishment of oversight processes in the manufacturing, warehouse and facilities area that ensure compliance with all relevant cGMP regulations. The position will also ensure the ongoing qualification status of all systems in the area. The position will also support the establishment and management of the batch record review process, as well as review of all record types within the quality management system prior to Qualified Person review. The position will be key to facilitating regulatory and customer inspections. The position will make required contributions to team goals, collaboration across all departments and influence key stakeholders.
Role and Responsibilities
- Quality Systems & GMP: Establish and maintain robust QA processes, batch record review, GMP training, and Quality Management Systems to ensure regulatory compliance.
- Manufacturing & Compliance Oversight: Provide QA oversight across manufacturing, warehousing, facilities, validation, change controls, specifications, and CMC changes, ensuring commercial readiness is maintained.
- Audits & Regulatory Readiness: Support regulatory and customer audits, Annual Product Quality Reviews, and ongoing compliance with global regulatory requirements (HPRA, EMA, FDA, PMDA, NMPA, etc.).
- Cross-Functional Collaboration: Build effective relationships with Plant teams, T&M colleagues, wider QA functions, and other stakeholders to ensure quality requirements are clearly understood and delivered from plant set-up onwards.
- External Communications: Ensure effective and robust communication with regulatory authorities, other Astellas sites, the wider QA organisation, and relevant industry groups.
- Leadership & Quality Culture: Champion Quality and Compliance across the Tralee Plant, mentor QA and wider Plant colleagues, and promote a strong, positive quality-focused culture.
Essential Qualifications
- Science based degree with experience in a cGMP compliance environment in an Aseptic Manufacturing Plant.
- Experience of supporting regulatory inspections and customer audits.
- QP Eligibility is desirable
Why Astellas
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organisational Values and Behaviours
Integrity
Innovation
Impact
One Astellas
Accountability
Courage
Sense of Urgency
Outcome Focus
Skills and Capabilities
Organizational Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.