Quality Assurance Compliance (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 100% onsite in Tralee, Ireland.

At  Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Purpose and 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.

Essential 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.

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

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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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