Global Quality Compliance Head

Company Description

At 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 Description

In 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.

Responsibilities

• Lead the TAPI Quality Compliance team of highly professional specialists in accordance to TAPI values and leadership standards
• Ensure 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.
• Establish 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 execution
• Ensure global quality oversight over Commercial operations
• Maintain 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 applicable

Coordinates within the Compliance Team the following task

• Perform ATR visits and lead, together with the Site Quality Head, inspection readiness activities at the sites
• Performance management and reporting
• Project management, monitoring, execution and reporting
• Coordinates the capacity of the compliance specialist in partnering with the sites to remediate any gaps identified in compliance
• Customer experience management - work with customer experience for general set up of QA and QC requests
• Coordinator 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
• Oversight to the evaluation of effectiveness of the corrective and preventive actions
• Quality risk assessments Inspection readiness
• Adherence to quality metric definition
• Data integrity governance others as per assignment and sites request
• Establish and monitor governance on data integrity requirements.
• Establish and manage the TAPI Change Control Forum
• Cooperate 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 organization

Qualifications

• Degree in Chemistry, Biology, Microbiology, Pharmacy or similar demonstrated knowledge in GXP regulations
• Very 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 requirements
• Ability to understand and execute against TAPI Quality Management System
• Knowledge product types and manufacturing operations
• Problem solving and good team work skills
• Proactive orientation, communication skills
• Proven influencing capabilities
• 15+ vears' experience in GMP environment, continuous professional development
• 10+ vears' experience in managerial tasks, to lead a quality department or organization
• Exposure to International working environment

Job Requirements

• Fluent in English
• Must travel regularly (up to 30% of time)

Additional Information

Make Your Mark with TAPI

Your 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!