Company DescriptionAt TAPI, we’re not just a company—we’re a community committed to advancing health from the core. As the world’s leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we’re shaping the future of health worldwide.Our strength lies in our people—a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives.Job DescriptionIn this role as Teva api Quality Compliance Head vou will lead and develop the team of TAPI Quality Compliance and will ensure that each site within TAPI receives the right level of support to maintain and enhance GMP compliance, to solve quality related service issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance to TAPI quality standards.ResponsibilitiesLead the TAPI Quality Compliance team of highly professional specialists in accordance to TAPI values and leadership standardsEnsure together with the Members of the TAPI Leadership team at all Sites within TAPI that the TAPI Quality Management System (QMS) is implemented and the local Quality Management Systems is up to and execute Global Quality related initiatives (e.g. Data Integrity Program, Compliance Enhancement Programs, At-any-time readiness (ATR) site visits, KPI improvements, including backlogs reduction)Oversight Global Quality Audits planning and executionEnsure global quality oversight over Commercial operationsMaintain the Electronic Quality Management Systems (i.e. tarLims, Trackwise, Priority (QA module)Responsible for the management of the TAPI Quality Council (scheduling, conduct, recording, follow up) and other meetings as applicableCoordinates within the Compliance Team the following taskPerform ATR visits and lead, together with the Site Quality Head, inspection readiness activities at the sitesPerformance management and reportingProject management, monitoring, execution and reportingCoordinates the capacity of the compliance specialist in partnering with the sites to remediate any gaps identified in complianceCustomer experience management - work with customer experience for general set up of QA and QC requestsCoordinator Role of the Notifications to Management process within the TAPI and the global Notifications to Management process, both in accordance to global standard including QAM and MAC meetings (numbering, issuing, assessment, follow up, closing, defining market action where applicable). Reporting of a monthly status update. Support of execution and coordination of recallsOversight to the evaluation of effectiveness of the corrective and preventive actionsQuality risk assessments Inspection readinessAdherence to quality metric definitionData integrity governance others as per assignment and sites requestEstablish and monitor governance on data integrity requirements.Establish and manage the TAPI Change Control ForumCooperate with other functions within Quality proiects and their role out. Act as a quality SME and support global compliance initiatives upon request Participates in audits upon request.Fosters knowledge sharing among sites within the TAPI organizationQualificationsDegree in Chemistry, Biology, Microbiology, Pharmacy or similar demonstrated knowledge in GXP regulationsVery good understanding and insight into the different aspects of quality functions like QC, OA, Quality Systems, Compliance, Microbiology, Documentation etc.Sound knowledge of regulatory standards and guidance in Pharmaceutical Industry and expectation of global regulatory bodies, including FDA, PMDA and Anvisa requirementsAbility to understand and execute against TAPI Quality Management SystemKnowledge product types and manufacturing operationsProblem solving and good team work skillsProactive orientation, communication skillsProven influencing capabilities15+ vears' experience in GMP environment, continuous professional development10+ vears' experience in managerial tasks, to lead a quality department or organizationExposure to International working environmentJob RequirementsFluent in EnglishMust travel regularly (up to 30% of time)Additional InformationMake Your Mark with TAPIYour journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Together, let’s shape the future of pharmaceuticals. Apply on top of this page and our talent acquisition team will be in touch soon!
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