If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. 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. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description:To assist the Quality Compliance Manager and other QA team members in the implementation of the Quality Systems at the KSP facility and associated contractor sites.Essential FunctionsKey Responsibilities / AccountabilitiesManaging and maintaining of the quality management system:Corrective and preventative actions (CAPA)DeviationsChange controlSupplier and customer complaintsQuality risk management (QRM)Leading root cause analysis (RCA)Liaising with global process owners to ensure consistency in the QMS between sites and functionsTraining in the QMSCollating QMS metrics and KPI dataPresenting QMS data at quality management review (QMR) meetingsQuality Vendor ManagementNew Supplier/Vendor onboardingInternal and External Audit managementDetailed Responsibilities / AccountabilitiesPrepares, reviews, updates and completes QMS processesEnsures training records are kept up to dateCarries out their work in a way that will not adversely affect their own, or others’ health, safety and security or the environment and reports any shortcomings in GW arrangementsEnsure all complaints are documented, investigated and closed out within agreed guidelines. That issues are escalated as requiredStrives to ensure quality events are closed within agreed timeframes and facilitates management of quality events across KSPAssisting in the assembly of the product quality reviewEnsuring that regulatory, marketing partners due diligence and other audit/inspections performed at GW are supported with efficient document retrieval and supply of the technical informationManagement of quality qualifications and approval of vendor to ensure compliance to regulations.Ensures vendors are maintained and monitored using a risk-based approach which links into the external auditing process and the business.Lead and support internal and external audits, report write up and response management.Assist in the creation of technical agreements, supplier agreements and quality risk assessmentsParticipate or leads projects to deliver improvements in productivity and efficiency in all areas relevant to complaintsAuthors and reviews all required quality documentsCreates training packages for QMS process at KSPAuthors and edits SOPs associated with the QMS at KSPRequired Knowledge, Skills, and Abilities Skills:Working knowledge of office IT packagesHigh level of written and verbal communication skillsAttributes and Behaviors:Motivated individuals that have extensive experience across many disciplines within the pharmaceutical industry and have spent a significant period of time within quality assurance, demonstrating the ability to develop quality systems.Required / Preferred Education and LicensesEducation:Typically, Bachelor’s degree (or equivalent) in science or related disciplinePost-graduate qualifications (Master’s, PhD) preferredExperience:Extensive work experience in the Pharmaceutical, Biotechnology or a related industryExperience working within a quality environment, including experience in GMP, GACP and GDP#LI-SP1#LI-onsite Jazz Pharmaceuticals is an equal opportunity/affirmative action 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 characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.