Primary Qualified Person 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 about 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 Primary Qualified Person is responsible for the batch release of drug product. Additional responsibilities include the development, implementation, maintenance and control of critical quality systems. This involves control of such items such as appropriate review of batch documentation/ data, development of Quality Assurance procedures, investigation of stability issues, review of all quality related changes including non-conformances, alerts and change controls, oversight of post-batch release related events, i.e. customer complaints, product security/suspected counterfeit and review of trending programmes and reporting of non-conformances from guidelines etc. Role and Responsibilities Batch Release & Compliance: Certify and release batches in line with Article 47 of Directive 2001/83/EC, Annex 16, cGMP, and Manufacturing Authorisation requirements, ensuring all manufacturing and QC checks are complete and compliant. Documentation & Quality Oversight: Review and approve batch-related documentation (e.g., deviations, OOS/OOT, change controls, supplier/contractor records), Product Quality Reviews (PQRs), MBRs, and processing instructions. Investigation & Risk Management: Oversee investigations into OOS, OOT, and major/critical non-conformances, ensure GMP-compliant documentation, and support risk identification and mitigation. Quality Systems & Governance: Participate in management and Quality System Reviews, monitor CAPA status, approve Quality Agreements, and ensure effective systems for returned goods disposition. Regulatory & External Engagement: Liaise with regulatory authorities, contract manufacturers, industry groups, and global QA peers; maintain awareness of evolving regulatory requirements and support implementation. Leadership & Operational Support: Contribute to management forums and major projects, coach QA team members, support local problem-solving, and promote a strong quality-focused culture across the site. Required Qualifications Science based degree with extensive experience in a cGMP compliance environment. Extensive experience with supporting Lyophilisation and all aspects of Aseptic Manufacturing. QP eligibility 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 Career | 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 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-ND1 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.
Graduate Systems Engineer About Astellas: At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners. About This Job: As a Graduate Systems Engineer, you will work within a systems team overseeing the day-to-day operations of autonomous systems, providing crucial support for Operations and Quality automation systems (Levels 1 to 3). The systems team is responsible for the end-to-end ownership of the design, development, configuration, management, compliance, integration, and continuous improvement of applications, ensuring the smooth and efficient execution of operations and quality processes. Additionally, you will serve as the primary custodian and owner of relevant systems within the site. These systems include, but are not limited to, DCS, PLC/SCADA, MES, LIMS, CMX, and Empower. Over time, team members will gain expertise in and provide support for all these systems. You will be part of an inclusive team that works to develop innovative therapies for patients. Key Activities for this Role: Design reliable and robust systems to meet business and process requirements for Process Control Systems (DCS and PLC/SCADA) and vendor-packaged equipment, ensuring integration with upstream and downstream systems like Filling Line, Utilities, MES, and Data Historian. Create, review, and approve automation and operational technology deliverables, including schedules, user requirements, design documents, and IQ/OQ/FAT protocols for L2 systems, ranging from standalone lab instruments to aseptic filling lines. Ensure the administration of cGMP-computerized systems maintains data integrity, including conducting periodic reviews and supporting relevant procedures. Diagnose and resolve technical problems through proactive problem-solving efforts, providing both short-term and long-term solutions for system issues. Ensure compliance with cGMP regulations, Health & Safety legislation, and other relevant standards while supporting the administration and maintenance of systems and technologies. Support system qualification and validation activities by attending and contributing to ensure alignment with procedural requirements. Essential Knowledge & Experience: Theoretical knowledge of Process Control System (DCS and PLC/SCADA) and vendor packaged equipment including integration to both upstream and downstream systems such as Filling Line, Utilities, MES, Data Historian etc. Good interpersonal and communication skills. Good organisational and planning skills. Ability to work on one's own initiative and take a proactive approach to all aspects of the role is essential. Good documentation practices. A very flexible approach to work and practices/procedures is required to ensure smooth operation of the department. Education/Qualifications: Bachelor's degree in technology or computer science or proven relevant in-depth experience. Additional Information: This is a 2-year, fixed-term contract. This position is on-site based in Tralee plant / County Kerry, Ireland. Candidates must be located within a commutable distance of the office. What We Offer: A challenging and diversified job in an international setting. Opportunity and support for continuous development. Inspiring work climate. 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. #LI-Tralee #LI-Onsite 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.
Training Administration Specialist 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. 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 responsible for providing a consistent and comprehensive AICL Learning Management System (LMS) process that supports the business in maintaining a stable supply of quality products to patients. This includes supporting record management in compliance with GMP requirements and delivering efficient training administration services. The role involves managing the GxP Learning Management System to ensure learning compliance, audit readiness, and the accuracy of learning data in line with GMP standards. Role and Responsibilities Perform daily LMS administration operations, support training record management (on-site and off-site), and respond to business end-user queries. Generate LMS training KPIs and compliance reports; ensure audit readiness by maintaining accurate learning data and documentation. Collaborate with third-party providers and internal teams to resolve system issues, and support LMS optimization, integration, and lean process improvement initiatives. Coordinate and manage training logistics, including scheduling, venue booking, raising POs, preparing materials, and communicating with participants. Maintain accurate training records, support trainers during sessions, and handle data tracking, reporting, and compliance documentation. Assist in developing training content and gathering feedback to drive continuous improvement of training programs and processes. Required Qualifications Minimum Level 6 Qualification in 3rd Level Institution in related area, ECDL, Microsoft Office or equivalent Preferred Qualifications Familiarity with Learning Management System (LMS), experience of working in a GMP environment and Previous experience in training administration, human resources, or a similar role is advantageous 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: Career | 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 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-CC1 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.
Lyophilisation Lead Engineer 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 100% onsite in Tralee, Ireland. Purpose & Scope Provide technical support to lyophilisation operations, engineering, and control systems to ensure efficient, compliant operations. Ensure GMP compliance and data integrity of computerised systems. Lead deviations, investigations, CAPAs, and root cause analysis. Drive continuous improvement using Lean Six Sigma. Manage projects, technology transfer, commissioning, and cross-functional collaboration. Apply strong analytical and automation/SCADA/PAT expertise. Role and Responsibilities Support lyophilisation operations and ensure achievement of production and project schedules. Maintain compliance with cGMP, ISO 14001, EMAS, Health & Safety, and Environmental legislation. Train and develop staff; maintain SOPs and documentation. Support Operational Excellence initiatives and promote strong teamwork and safety culture. Required Qualifications Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Sciences, Bioprocess Engineering, Biotechnology, or related field, or extensive relevant experience. Preferred Qualifications Experience in lyophilisation process development or operations (e.g., Lyomax). Expertise in aseptic vial lyophilisation, CIP/SIP/FIT, process instrumentation, control systems, qualification, and validation. Strong organisational, interpersonal, verbal, and written communication skills. Ability to work independently or as part of a team. What awaits you at Astellas? Global collaboration. Real-world patient impact. Relentless innovation. A culture of growth. Our Organizational Values and Behaviors 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, 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 anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help. #LI-JU1 #LI-Onsite #LI-Tralee 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.
Manufacturing Engineer 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 seek individuals who thrive in dynamic settings, embrace innovation, and contribute to meaningful patient impact. Location and Working Environment This position is 100% onsite in Tralee, Ireland. Purpose & Scope Responsible for installation, maintenance and troubleshooting of biologics manufacturing equipment, ensuring compliance with GMP and regulatory standards while supporting process improvements and equipment performance optimization. Role and Responsibilities Provide daily technical equipment support and troubleshooting. Develop procedures and training to improve equipment operation. Lead technical problem solving and process improvement initiatives. Support validation protocol development and execution. Contribute to lean manufacturing and cross-functional alignment. Gain expertise in aseptic filling and lyophilization systems. Required Qualifications Bachelor's degree in Engineering or related field, or equivalent experience. Experience in biologics/pharmaceutical manufacturing and GMP environments. Preferred Qualifications Experience with aseptic filling and lyophilization processes. Strong collaboration, communication and problem-solving skills. What awaits you at Astellas? Global collaboration with life-science leaders. Impactful work that improves patient outcomes. Innovation-driven environment. Supportive culture focused on growth. Our Organizational Values and Behaviors Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits Career | 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 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-MO1 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.
Process Engineer 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 welcome individuals who thrive in highly technical environments, embrace problem-solving and contribute to operational excellence. Location and Working Environment This position is 100% onsite in Tralee, Ireland. Purpose & Scope Provide technical support to operational and engineering areas ensuring efficient production performance, system compliance, and high-quality manufacturing standards across DCS and other control systems. Role and Responsibilities Support DCS and control systems ensuring compliance, performance and data integrity. Lead problem-solving and troubleshoot process equipment to develop long-term solutions. Manage CAPA implementation and ensure timely completion. Drive process optimisation, cost-saving and energy-reduction initiatives. Lead Lean Six Sigma CI activities and report area performance. Support technology transfer and commissioning of new processes and systems. Ensure compliance with cGMP, ISO, H&S, EMAS and environmental legislation. Required Qualifications Bachelor's degree in Engineering (Chemical/Biochemical) or equivalent experience. Industry experience in process engineering within regulated manufacturing. Technical proficiency in filtration, purification, control systems, validation and instrumentation. Proven ability to independently progress projects and support complex engineering activities. Lean Six Sigma Yellow Belt or equivalent analytical expertise. Preferred Qualifications Direct experience in drug manufacturing. Experience in cGMP start-up environments. Experience with DCS/PLC systems. What awaits you at Astellas? Collaboration with global experts in science and engineering. Direct contribution to safe, efficient and high-quality manufacturing. Innovation-oriented culture with development pathways. Supportive working environment focused on continuous improvement. Our Organizational Values and Behaviors Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits Learn more at: 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 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.
A global life sciences company is seeking a Head of Kerry QA to lead and manage Quality Assurance activities at the Kerry Plant in Ireland. This full-time role requires establishing a robust QA system, ensuring compliance with regulatory standards, and leading audits and inspections. Candidates must have a Bachelor's degree in a science-related field and significant experience in pharmaceutical QA leadership. The ideal applicant will possess strong leadership skills and proficiency in relevant quality systems. #J-18808-Ljbffr
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. 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 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. 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. #J-18808-Ljbffr
Project Lead Engineer 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 100% onsite in Tralee, Ireland. Purpose & Scope Plan, execute, and deliver engineering projects supporting biopharmaceutical manufacturing, facility upgrades, technology transfers, and process improvements. Ensure projects meet safety, quality, regulatory and business requirements. Coordinate cross-functional teams and external vendors to ensure successful project delivery. Role and Responsibilities Lead end-to-end engineering projects including scopes, schedules, budgets, risks, handovers, and reporting. Provide engineering expertise across equipment, utilities, automation, and process systems; develop URS/design docs; review drawings and FAT/SAT protocols. Collaborate with QA, Validation, Manufacturing, Supply Chain, EHS, and contractors; support design reviews, hazard assessments, and change controls. Ensure GMP/GDP, FDA, EMA, ICH compliance; support commissioning, qualification, FAT/SAT and maintain audit-ready documentation. Prepare capital justifications, manage CAPEX budgets, track costs, and support procurement and vendor negotiations. Identify and mitigate project risks, manage documentation and tracking tools, evaluate outcomes and drive continuous improvement. Required Qualifications Strong knowledge of GMP, validation, and pharmaceutical manufacturing. Proficiency in project management tools (e.g., MS Project, Primavera). Excellent analytical, leadership, organisational and troubleshooting skills. Proven capability managing multiple projects in a regulated environment. Preferred Qualifications Bachelor's degree in Engineering or significant relevant experience. Experience managing pharmaceutical engineering projects, equipment vendors, and cross-functional teams. What awaits you at 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,whereyou'llhave the opportunity to shape the future of healthcare. A Culture of Growth: Chart your own course within a supportive environment thatvalues your contributions, champions your development, and empowers you topursue your passions. Our Organizational Values and Behaviors Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits Astellas offers a comprehensive and competitive benefits package. Learn more at 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 anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help. #LI-Tralee #LI-Onsite #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.
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.
