Manager, Audits & Inspections (GCP / GLP)

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter. OverviewJazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients'' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.We are looking for the best and brightest talent to join our team. If you''re looking to be a part of a company with an unwavering commitment to improving patients'' lives and being a great place to work, we hope you''ll explore our career openings and get to know Jazz Pharmaceuticals. Position ProfileThis position will lead and participate in various types of GCP/GLP compliance audits for Jazz Pharmaceuticals'' development programs including but not limited to, clinical investigator sites, service providers, and internal systems and processes globally. In addition, this position is responsible for supporting regulatory agency inspections. Essential Job Functions:Conduct/support GCP/GLP compliance audits of clinical investigator sites, service providers and internal system/process audits in accordance with the annual audit plan to determine compliance status and identify compliance risksPrepare audit reports and communicate audit findings to audit stakeholders as well as R&D Quality Management ensuring understanding of observations Collaborate with clinical compliance leads to identify audit needs and follow up post-audit activities to ensure appropriate implementation of CAPA, and monitoring successful completion of action itemsAssist in managing and training external auditors ensuring compliance with Jazz Pharmaceuticals auditing standards and proceduresProvide pertinent data to support quality and compliance metrics and trendingAssist in the planning of clinical quality audit programsDevelop and maintain study specific audit plans (SSAPs)Participate in strategic planning of organizational activities, as required.Support inspection management lead to maintain Jazz R&D inspection readiness at times Participate in regulatory agency inspection activities pertinent to R&DDomestic and international travel is requiredQualificationsMinimum 5 years pharmaceutical or biotechnology industry experience in performing audits and participating in regulatory inspectionsGCP audit experience is required, GVP and GLP experience is valuable but not requiredKnowledge/understanding of the perspectives of regulatory agenciesEducation 4-year degree OR 10+ years'' industry experience plus applicable industry certificationsIndustry certification in Regulatory Affairs and / or Quality Assurance is preferred but not requiredCompetenciesAbility to manage multiple priorities simultaneously and work efficiently in a fast paced cultureStrong and clear understanding of Good Clinical Practices (GCP)Strong knowledge of applicable global regulatory requirementsMust be disciplined, detail orientated and excel in personal time managementCollaborate and ability to interact all levels of the organizationThis position requires highly diplomatic and tactful with critical reasoning skillsStrong problem solving and analytical skillsExcellent written and verbal communications skillsAbility to work independently while also supporting/working in teams collaborativelyJazz 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.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.

Created: 2021-11-29