Quality Assurance Compliance
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 are seeking individuals who thrive in dynamic environments, embrace new ideas and are committed to making a meaningful impact.
Location and Working Environment
This position is 100% onsite in Tralee, Ireland.
Purpose & Scope
- The role is part of the Quality Assurance function within the Astellas Ireland Co. Ltd. Tralee Plant Aseptic Manufacturing Facility.
- Responsible for the on-going development, implementation and maintenance of GxP compliance. Responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant GxP operations.
- This role will take a lead in supporting the Tralee Plant QMS development and overall maintenance. eQMS metrics development will be a key responsibility area, supporting ICHQ10, Tier 4 and overall QMS Metrics management.
- Responsibilities include ensuring adherence to agency regulations (GxP) and guidances, industry best practices, local regulations, and internal policies and procedures.
- This position works closely with Validation, Engineering, Manufacturing, Facilities, Document/Data Management, Quality Control (QC) and other GxP supporting functions to ensure compliance.
- This is accomplished by direct collaboration and oversight, supporting Validation, Facilities/Engineering, Manufacturing Operations, QC activities and the review/audit of data and reports as specified by Standard Operating Procedures.
- This role will support inspection/ audit readiness and coordination of GMP inspection/ audit support activity.
Role and Responsibilities
- Quality Management Systems (QMS): Support and maintain the site QMS and eQMS in compliance with GxP requirements, including governance, metrics, risk management, and continuous improvement.
- Quality Oversight & Compliance: Review and approve quality records, validation, change controls, and documentation (TrackWise/Vault), ensuring timely investigations and adherence to SOPs and regulatory standards.
- Audits & Inspections: Coordinate self-inspections, regulatory, customer, and corporate audits, manage CAPAs, and support inspection readiness, responses, and close-out activities.
- Quality Programs & Continuous Improvement: Lead initiatives including Product Quality Reviews, Culture of Quality, complaint management, and risk register maintenance to drive operational excellence.
- Stakeholder & Regulatory Engagement: Collaborate with cross-functional teams, suppliers, global quality teams, regulatory authorities, and industry groups to ensure effective quality communication and compliance.
- Leadership & Team Development: Foster a strong quality culture, influence cross-functional teams, mentor colleagues, and support the development of QA staff and site-wide quality capability.
Required Qualifications
- Science-based degree with relevant experience in a cGMP compliance environment.
- Experience within a QA function supporting an aseptic manufacturing plant is essential.
- Experience supporting regulatory inspections, customer audits and cross-functional quality systems/ QMS development, management and maintenance is required.
What awaits you at Astellas?
- Global collaboration and connection with like‑minded life‑science leaders.
- Real‑world patient impact through transformative therapies.
- Relentless innovation at the forefront of scientific advancement.
- A culture of growth that supports your development and ambitions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
Learn more at: https://www.astellas.com/en/careers
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.
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