Ph3Company Description /h3pAt 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. /ppOur 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. /ph3Job Description /h3pIn 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. /ph3Responsibilities /h3ulliLead the TAPI Quality Compliance team of highly professional specialists in accordance to TAPI values and leadership standards /liliEnsure 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 date. /liliEstablish 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) /liliOversight Global Quality Audits planning and execution /liliEnsure global quality oversight over Commercial operations /liliMaintain the Electronic Quality Management Systems (i.e. tarLims, Trackwise, Priority (QA module) /liliResponsible for the management of the TAPI Quality Council (scheduling, conduct, recording, follow up) and other meetings as applicable /li /ulpCoordinates within the Compliance Team the following task /pulliPerform ATR visits and lead, together with the Site Quality Head, inspection readiness activities at the sites /liliPerformance management and reporting /liliProject management, monitoring, execution and reporting /liliCoordinates the capacity of the compliance specialist in partnering with the sites to remediate any gaps identified in compliance /liliCustomer experience management - work with customer experience for general set up of QA and QC requests /liliCoordinator 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 recalls /liliOversight to the evaluation of effectiveness of the corrective and preventive actions /liliQuality risk assessments Inspection readiness /liliAdherence to quality metric definition /liliData integrity governance others as per assignment and sites request /liliEstablish and monitor governance on data integrity requirements. /liliEstablish and manage the TAPI Change Control Forum /liliCooperate 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. /liliFosters knowledge sharing among sites within the TAPI organization /li /ulh3Qualifications /h3ulliDegree in Chemistry, Biology, Microbiology, Pharmacy or similar demonstrated knowledge in GXP regulations /liliVery good understanding and insight into the different aspects of quality functions like QC, OA, Quality Systems, Compliance, Microbiology, Documentation etc. /liliSound knowledge of regulatory standards and guidance in Pharmaceutical Industry and expectation of global regulatory bodies, including FDA, PMDA and Anvisa requirements /liliAbility to understand and execute against TAPI Quality Management System /liliKnowledge product types and manufacturing operations /liliProblem solving and good team work skills /liliProactive orientation, communication skills /liliProven influencing capabilities /lili15+ vears' experience in GMP environment, continuous professional development /lili10+ vears' experience in managerial tasks, to lead a quality department or organization /liliExposure to International working environment /li /ulh3Job Requirements /h3ulliFluent in English /liliMust travel regularly (up to 30% of time) /li /ulh3Additional Information /h3pbMake Your Mark with TAPI /b /ppYour 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! /p /p #J-18808-Ljbffr