Quality Assurance for Integrated Batch Release (IE)
Notify me about similar jobsAbout this opportunity
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 100% onsite in Tralee, Ireland.
Purpose and Scope
The role is part of the Quality Assurance function within the Astellas Ireland Co. Ltd. Tralee Plant Aseptic Manufacturing Facility. The QA resource will provide quality oversight and support for the qualification and validation of integrated GxP systems required to enable a compliant digital batch release process and review-by-exception operating model. The role will ensure that system design, configuration, integration, testing, data flows and associated controls meet applicable GxP regulations and guidance, data integrity requirements, industry best practices, local regulations, and internal policies and procedures. Working closely with Validation, Engineering, Manufacturing, Facilities, Digital/IT, Document and Data Management, Quality Control (QC), and other GxP-supporting functions, the role will review and approve qualification strategies, protocols, evidence, deviations, risk assessments and reports, and verify that system-generated data and exception-based review processes are accurate, complete, reliable and suitable to support batch disposition and release.
Role and Responsibilities
Provide QA oversight and approval for the qualification and validation of integrated GxP systems, ensuring risk-based strategies, data integrity, GMP compliance, and readiness to support digital batch release and review-by-exception processes.
Partner with Validation, Manufacturing, Laboratory, Quality, and system owners to define and approve requirements for digital batch release and review-by-exception, including CPP/CQA limits, exception and alarm management, audit trails, electronic records/signatures, data workflows, interfaces, traceability, access controls, segregation of duties, escalation, and contingency arrangements.
Provide hands-on QA support to internal teams, suppliers, and contractors, ensuring compliance with GxP requirements, SOPs, validation expectations, and quality standards; support the development, review, and approval of GMP documentation, including specifications, protocols, reports, SOPs, deviations, CAPAs, and change controls.
Collaborate with equipment owners, Validation, Engineering, and cross-functional stakeholders to ensure facility, equipment, software, and technical systems are appropriately qualified and validated, with effective quality requirements established from project initiation.
Support regulatory and customer audits, regulatory communications, and collaboration with other QA organisations, Astellas sites, and relevant industry groups, ensuring effective communication and continued commercial and regulatory readiness.
Provide QA leadership and influence across the plant, fostering a strong quality culture, supporting staff development, and ensuring QA activities and priorities align with business needs and GMP requirements.
Essential Qualifications
Science based degree with experience in a cGMP compliance environment, experience of QA function in an aseptic manufacturing plant essential.
QP Eligible preferably
Benefits
Careers | Astellas
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
.
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 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.
#LI-Tralee
#LI-Onsite
#LI-JU1
]]>
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 1052 comparable Quality roles across 134 biopharma companies.
Salary context
204 of 1052 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 1052 comparable roles
+ 43 more countries
Seniority mix
515 of 1052 peers have a known seniority level
Therapeutic area mix
2 of 1052 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.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
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.