Jazz Pharmaceuticals is a global biopharma company that transforms lives of patients and their families by developing life-changing medicines for serious diseases.We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.The Senior QA Specialist is a key member of the team responsible for successful day-to-day running of Quality Operations and Quality Management System (QMS) for the facility. This role will support other organisational objectives, represent quality on cross-functional and/or cross-company teams, and manage supplier qualification program.Key ResponsibilitiesRepresent Quality during manufacturing operations and provide guidance in a collaborative fashion.Ensure manufacture of quality products in accordance with product licenses and filings.Perform production AQLs, incoming inspection and disposition of raw materials, consumables, packaging.Review and implement manufacturing related documents.Implement and oversee quality systems to ensure compliance with regulatory guidelines and Jazz policies.Provide quality and cGMP input and oversight of the manufacturing facility.Manage and support Supplier Management program, including qualifications and re-qualifications of suppliers and materials.Generate Quality Systems metrics and prepare presentations suitable for Senior Management review.Generate and approve Quality documents.Support validation activities and review technical support documentation.Manage QMS system to ensure compliance and adherence to site metrics.Manage QA responsibilities of external manufacturers of APIs.Support site compliance program and participate in third-party audits and inspections.Partner with other SMEs to understand changes in the regulatory environment and coordinate quality involvement.Lead and support initiatives for QA improvement and GMP compliance.Lead and support site-wide projects and continuous improvement processes.Requirements4-7 years' experience in finished product pharmaceutical/biologics manufacturing.Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.Highly flexible, works well in a team environment, and has necessary skills to organize, communicate, influence and lead.Demonstrated capability in establishing collaborative working relationships at all levels.Possess fundamental scientific thought processes and ability to apply this to overcome problems.Recognize areas for improvement and use initiative to implement change programs.Ability to work independently, as well as a member of a team in a dynamic environment.Ability to deliver objectives on time, every time, while meeting all compliance and cost targets.Ability to generate documentation which is of a high standard.Education and LicensesBSc in science discipline required.Lead auditor certification highly desirable.Qualified Person experience or educational requirements desirable.