Head of Kerry QA - Full-Time (Onsite) 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 . 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. Location and Working Environment This position is based in the Kerry Plant and will require onsite working. This position will require Infrequent overseas meetings. Due to different Market time zones flexibility to join Calls/Webex outside normal hours is often required Working Hours This is a full-time, permanent position based onsite in Kerry, Ireland. Purpose & Scope This role is responsible for establishing and maintaining a robust Quality Assurance system that ensures compliance with global regulatory standards and supports the safe, effective, and consistent production of pharmaceutical products. It oversees all QA activities including audits, documentation, deviation management, and validation oversight. The position exists as a distinct leadership function to embed a strong quality culture across the site and to safeguard patient safety and regulatory integrity. Role and Responsibilities The Head of Kerry QA is responsible for leading and managing all Quality Assurance (QA) activities at the Kerry Plant to ensure that pharmaceutical products are manufactured in compliance with applicable regulatory requirements and internal quality standards. Key responsibilities include: Quality Management System (QMS) Oversight Develop, implement, and continuously improve the site QMS in alignment with global Astellas standards and regulatory expectations (EU GMP, FDA CFR, etc.). Ensure effective document control, including SOPs, Master Batch Records, and Technical Agreements. Lead the periodic review and revision of the QMS in response to regulatory changes or audit findings. Audit and Inspection Readiness Plan, coordinate, and lead internal and external audits, including those by regulatory authorities (e.g., HPRA, EMA, FDA). Ensure timely closure of audit findings and implementation of corrective and preventive actions (CAPAs). Deviation and CAPA Management Oversee the investigation of deviations, customer complaints, and product quality issues. Ensure robust root cause analysis and implementation of effective CAPAs, with trend analysis and reporting to senior management. Continue: Role and Responsibilities Training and Compliance Ensure that all QA personnel and relevant site staff receive appropriate GMP training, including annual refreshers. Promote a strong quality culture through coaching, communication, and compliance initiatives. Validation and Change Control Approve validation protocols and reports for equipment, processes, and cleaning. Review and approve change controls, including those requiring global coordination. Regulatory Support Ensure QA review and approval of regulatory submissions and post-approval changes. Maintain compliance with the Manufacturing Authorization and support dossier updates. Cross-functional Collaboration Provide QA expertise and support to production, engineering, regulatory affairs, and global quality teams. Participate in global QA forums, working groups, and strategic initiatives. Lead the initiatives across Pharma QA As a member of the Pharma QA leadership team, lead the reforms of Pharma QA business operations in response to the necessity of the time. Accountabilities The Head of Kerry QA is ultimately accountable for ensuring that all QA systems and processes are effective, compliant, and aligned with the company's mission to deliver safe and effective medicines. Specific accountabilities include: Ensuring the site remains in a state of continuous inspection readiness. Guaranteeing that all QA decisions are risk-based, scientifically sound, and patient-focused. Representing the QA function during regulatory inspections and corporate audits. Maintaining oversight of all QA metrics and reporting to senior leadership on quality performance and risks. Ensuring that QA resources are adequately trained, engaged, and aligned with site and global objectives. Upholding the integrity of the QMS and ensuring timely and compliant batch release support. Required Qualifications Bachelor's degree in a science-related field (Pharmacy, Chemistry, Biology, etc.), or equivalent. Preferred Qualifications Master's degree or PhD in Pharmacy, Pharmaceutical Sciences, or a related scientific discipline. Significant experience in pharmaceutical Quality Assurance. Substantial experience in a QA leadership or management role. Proven track record of managing regulatory inspections and audits (e.g., HPRA, EMA, FDA). Demonstrated ability to lead QA teams and effectively communicate with cross-functional and global stakeholders. Strong working knowledge of EU GMP, FDA CFR, and other relevant global regulatory requirements. Proficiency in English (written and spoken). Familiarity with electronic quality systems (e.g., TrackWise, LIMS, Empower). Postgraduate qualification in Quality Management, Regulatory Affairs, or Pharmaceutical Technology. Eligibility to be registered as a Qualified Person under EU Directive 2001/83/EC. Experience in solid dosage and/or aseptic manufacturing environments. Familiarity with cleaning validation, environmental monitoring, and sterile product handling. Direct involvement in inspections by multiple regulatory bodies (e.g., FDA, EMA, PMDA). Experience with global regulatory submissions and post-approval change management. Advanced user of quality systems such as TrackWise, LIMS, Empower, and ADMS. Experience with digital transformation or automation of QA processes. Proven success in leading cross-functional quality improvement or transformation initiatives. Experience in embedding a quality culture and driving operational excellence (e.g., Lean, Six Sigma). Active participation in industry groups (e.g., PDA, ISPE, BPCI) or contribution to regulatory consultations. What awaits you at Astellas? Global collaboration: Work within a connected global community dedicated to improving patient lives. Real-world patient impact: Contribute to life-changing therapies that help people worldwide. Relentless innovation: Be part of an organisation pushing scientific and operational boundaries. A Culture of Growth: Thrive in a supportive workplace that values development and progression. Our Organisational Values and Behaviours Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits Careers | Astellas 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. Authentic communication will only originate from verified company email addresses or official LinkedIn profiles. #LI-Onsite #LI-Killorglin #LI-JU1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
