Global Quality Compliance Head

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.

Key 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