Quality Assurance Operations (IE)
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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
Careers | Astellas
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.
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Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1041 comparable Quality roles across 132 biopharma companies.
Salary context
196 of 1041 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1041 comparable roles
+ 39 more countries
Seniority mix
508 of 1041 peers have a known seniority level
Therapeutic area mix
2 of 1041 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.