PHARMA QUALITY HEAD

Job Description : PHARMA QUALITY HEAD IRELAND Open to International candidates with 25+ years experience This position is based in Tralee, Ireland. This position requires you to be 100% on site / in the office. Purpose and Scope The Quality Assurance Operations role will be primarily responsible for ensuring compliance of all manufacturing activities that form part of the Astellas Ireland Tralee Plant operations. Responsibilities will include establishment of oversight processes in the manufacturing, warehouse and facilities area that ensure compliance with all relevant cGMP regulations. The position will also ensure the ongoing qualification status of all systems in the area. The position will also support the establishment and management of the batch record review process, as well as review of all record types within the quality management system prior to Qualified Person review. The position will be key to facilitating regulatory and customer inspections. The position will make required contributions to team goals, collaboration across all departments and influence key stakeholders. Role and Responsibilities Quality Systems & GMP: Establish and maintain robust QA processes, batch record review, GMP training, and Quality Management Systems to ensure regulatory compliance. Manufacturing & Compliance Oversight: Provide QA oversight across manufacturing, warehousing, facilities, validation, change controls, specifications, and CMC changes, ensuring commercial readiness is maintained. Audits & Regulatory Readiness: Support regulatory and customer audits, Annual Product Quality Reviews, and ongoing compliance with global regulatory requirements (HPRA, EMA, FDA, PMDA, NMPA, etc.). Cross-Functional Collaboration: Build effective relationships with Plant teams, T&M colleagues, wider QA functions, and other stakeholders to ensure quality requirements are clearly understood and delivered from plant set-up onwards. External Communications: Ensure effective and robust communication with regulatory authorities, other Astellas sites, the wider QA organisation, and relevant industry groups. Leadership & Quality Culture: Champion Quality and Compliance across the Tralee Plant, mentor QA and wider Plant colleagues, and promote a strong, positive quality-focused culture. Essential Qualifications Science based degree with experience in a cGMP compliance environment in an Aseptic Manufacturing Plant. Experience of supporting regulatory inspections and customer audits. QP Eligibility is desirable

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