DescriptionValidation LeadAbout AstellasAt 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.The OpportunityAs the Validation Lead role you will be responsible for overseeing the daily operations of the Validation team. This role involves managing a team of Validation Engineers (Staff and outsourced service providers) coordinating activities, and implementing policies and procedures to enhance operational efficiency.You will ensure that facilities, utilities, equipment, computerized systems, manufacturing processes, cleaning procedures, analytical methods, and aseptic operations consistently perform as intended and reliably produce safe, effective, and compliant biopharmaceutical products. Your role provides strategic leadership for the site validation lifecycle—planning, execution, review, approval, and maintenance—aligned with current Good Manufacturing Practices (GMP), data integrity principles, and risk-based methodologies. You will serve as the primary owner of the Site Validation Master Plan (VMP), champions cross-functional governance, and drives continuous improvement to maintain a validated state throughout the product and system lifecycle.Your position will be responsible for managing, coaching and developing all aspects of these functions with input and local accountability for strategy, forward planning, safety, quality, delivery, cost and service performance.Key ResponsibilitiesLeadership & People Development: Lead and develop the Validation team and future leaders through clear ownership, coaching, feedback, succession planning, and by fostering an engaged, psychologically safe, high-performance culture aligned with Astellas values.Operational Excellence & Performance: Ensure stable supply, delivery of departmental objectives, resolution of issues, effective management of multiple priorities and projects, and continuous improvement through ambitious targets, KPIs, and innovative ways of working.Compliance & Governance: Maintain full compliance with GMP, GDP, environmental, safety, and corporate governance requirements, ensuring audit readiness, data integrity, adherence to validation standards, and timely, accurate reporting.Strategic Alignment & Business Impact: Contribute strongly to site and global strategy, deliver strategic projects on time and within budget, anticipate future trends and skill needs, and drive opportunities that advance long-term business objectives.Technology, Change & Knowledge Management: Lead implementation of new products, technologies, systems, and procedures, ensuring compliant change management while maintaining and transferring critical technical knowledge and expertise.Collaboration, Continuity & Risk Management: Build strong cross-functional and global partnerships, support business continuity and crisis management, mitigate risks, deputise as required, and ensure teams, systems, and infrastructure are prepared for future growth.Preferred ExperienceExperience & Technical Expertise: Extensive experience in a similar role, ideally within a cGMP start-up environment, with strong technical competence, validation leadership capability, and a commitment to continuous professional development and improvement.Delivery & Project Leadership: Proven ability to independently progress complex technical projects, support commissioning and maintenance of cGMP manufacturing, manage multiple priorities, adapt to changing needs, and contribute to or lead cross-functional project teams.Communication & Ways of Working: Excellent organisational, interpersonal, verbal, and written communication skills, with the ability to work effectively on own initiative or collaboratively, and an openness to new ideas and approaches.EducationBachelor's degree (or equivalent) in a Scientific discipline or proven relevant in-depth experience.Additional InformationThis is a permanent full-time position.Position is based in Tralee – Ireland.This position requires you to be 100% on site / in the office.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. 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