PPress Tab to Move to Skip to Content Link /ppSelect how often (in days) to receive an alert: /ph3Sr. Manager, Microbiology Quality Compliance Expert 1 /h3pDate: Jul 26, 2025 /ppLocation:pSanthia, Italy, 00 /p /ppJob Id: 62539 /ppTAPI is the leading international supplier of active pharmaceutical ingredients (APIs). Withbrthe industry's broadest portfolio including over 350 API products, TAPI is the go-to globalbrsupplier for APIs, supporting 75% of the top 50 global pharmaceutical companies.brHeadquartered in Israel, TAPI employs more than 4,000 professionals at 13 sites worldwide.brWe provide superior product quality and excellent customer service. /ph3bThe opportunity /b /h3pWe are looking for a Sr Manager, Microbiology-Quality Compliance Expert - TAPI.brThe main purpose of your job will be to ensure that the Microbiology laboratories, systems, procedures related to Quality Compliance System at TAPI sites is in place, securing compliance of activities, OOS investigations, Micro CCS, quality risk management, escalation of risks, and continuous improvement. Your role will include providing governance through strong collaboration with manufacturing site operations to foster excellence in inspection management and inspection readiness at TAPI sites. You will support manufacturing site remediation activities directly.brThis role will ensure that each site receives the right level of support to sustain and continuously improve GMP compliance related to Microbiology and other quality compliance support, to strategize the development and overall implementation of remedial plans, to solve quality-related compliance issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance with TAPI standards. Moreover, you will foster and develop onsite Quality culture across all sites. /ph3bHow you’ll spend your day /b /h3p• Support the Implementation of the Site Inspection Readiness Program focusing on Microbiology labs and related areasbr• Input, Review and Approval of Complex Investigations ( OOS, Deviations, Incidents, etc.)br• End to End Support for Health Authority Inspections focused on Microbiological aspectsbr• Support the Implementation of Quality Risk Managementbr• Review and Monitor Quality Improvement Plansbr• Train Site Colleagues on the Microbiology fundamentals, investigations, and Corporate Standard Systembr• Support Global Quality Compliance Initiatives eg; Cross contamination strategiesbr• Data Reliability assessments, gap evaluations, GxP data mapping in the micro labsbr• Review global TAPI policies and standards and provide inputsbr• Expected to spend reviewing QMS areas outside microbiology subject that related to QIPs, Data trending, signal detection, managing quality forums, leading CoPs related to Microbiology and relevant Quality management systems ( CAPA, Investigations, QRM etc) /ppCoordinates within the Compliance Team the following tasks: /pp• Establish and monitor governance on data integrity requirements.br• Cooperate with other functions on Quality projects and their role out.br• Act as a quality SME and support global compliance initiatives upon requestbr• Participate in audits upon request.br• Fosters knowledge sharing among sites within the TAPI /ph3bYour experience and qualifications /b /h3p• Degree in Industrial Microbiology and demonstrated knowledge in cGXP regulations.br• 10+ years' experience in GMP environment, continuous professional development 5+ years' experience in Microbiology laboratory, managerial tasks, organization Exposure to International working environmentbr• Mix of experience in Micro, Quality systems would be preferred.br• Very good understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, etc.br• Sound knowledge of regulatory standards and guidance in Pharmaceutical Industry and expectation of global regulatory bodies, including US FDA, PMDA and ANVISA requirementsbr• Performance management and reportingbr• Project management, monitoring, execution and reportingbr• Problem solving and good team work skillsbr• Proactive orientation, communication skillsbr• Proven influencing capabilitiesbr• Fluent in English /ppTAPI will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process. /ph3bAlready Working @TAPI? /b /h3pIf you are a current TAPI employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to TAPI employees. Use the following link to search and apply: Internal Career Site /ppThe internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. /ph3bTAPI's Equal Employment Opportunity Commitment /b /h3pTeva Pharmaceuticals is committed to equal opportunity in employment. It is TAPI's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. /p #J-18808-Ljbffr