Quality Assurance - Supplier Oversight
About Astellas
At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges, placing the patient at the heart of everything we do. Through our global vision for Patient Centricity, we integrate the patient experience into our everyday working practices. We have developed ground breaking medicines in immunology, oncology and urology, improving and saving the lives of patients worldwide. 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 Quality Assurance Supplier Oversight role will be primarily responsible for ensuring all suppliers (materials and services) associated with the Tralee plant are qualified to the appropriate standards. All information will need to be collated and recorded in the appropriate parts of the quality management system.
- Review and approval of all associated documentation, ensuring appropriate agreements are in place with all suppliers and oversight of the requalification process will also form key parts of the role. Ensuring close collaboration with QA across all departments will also be key.
Role and Responsibilities
- Establish and maintain a robust Quality Management System (QMS) ensuring compliance with global regulatory authorities (e.g., HPRA, EMA, FDA) and supporting regulatory submissions and product specifications.
- Ensure effective supplier quality management, including supplier qualification, external audits, and implementation of Quality Agreements with vendors and customers.
- Provide QA oversight of validation, CQV, and change control activities, including approval of validation documentation, internal and global change controls, and CQV phases (e.g., FAT/SAT).
- Author, review, and approve GMP documentation (SOPs, specifications, protocols, reports) and support preparation of Annual Product Quality Reviews.
- Support audit readiness and regulatory interactions, including participation in regulatory/customer audits and communication with authorities, suppliers, and industry groups.
- Provide leadership and cross-functional collaboration, promoting a strong quality culture, supporting team development, and delivering GMP training and QA guidance across the plant.
Required Qualifications
- Science based degree with experience in a cGMP compliance environment.
- Experience of QA function in an aseptic manufacturing plant.
- Experience of participating in regulatory inspections and customer audits.
- Qualified GMP Auditor
Essential Knowledge & Experience
- Validation Science/ Engineering based degree.
- Experience in establishing and cultivating a Culture of Quality.
- 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
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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