Head of Quality Manufacturing, EU, India & LATAM Solids & LCO cluster

The opportunity

The role is accountable to lead and manage all quality activities in the cluster. This includes Quality oversight and support over Teva manufacturing sites, suppliers, and its Quality Compliance processes. The Quality oversight has to ensure the quality of our products, compliance with regulations, and that the products are developed, manufactured, and supplied in a timely manner, securing uninterrupted supply to internal and external customers.

In addition, the role provides the management infrastructure and business processes which ensure that the right capabilities and capacity are in place to ensure quality-compliant decisions, and inspection readiness is confirmed by successful authority inspections. The role also includes a responsibility for driving proactive quality risk management processes and mindset across the sites, fostering a culture of continuous improvement and risk-based thinking.

In addition, the incumbent is leading TEVA´s offshoring centers for Stability Testing and PQR/APR Compilation.

This role can be based in any Teva location in Europe.

40 - 50% international travel expected.

• Lead the Site Quality Heads and their organizations in the manufacturing sites and ensures independent decision making related to product quality and Quality compliance aspects.
• Develop projects to simplify business processes in Quality in accordance with Teva's regulatory requirements and standards, driving the tools of the Teva Lean Management System and a proactive approach to risk management.
• Sponsor the execution of strategic compliance initiatives and remediation activities as applicable.
• Build and manage the appropriate infrastructure to manage and improve Quality relevant relations to external suppliers driving standardization and efficiencies.
• Ensure that Quality compliance is a critical parameter to secure supply for internal and external costumers.
• Significantly influence strategy as it relates to the Quality function, local and global Quality compliance, Quality operations and Quality Relation management.
• Develop together with Quality Compliance strategic plans driving toward the achievement of company quality compliance, business and financial goals, monitored by key performing indicators and the adherence to well set targets and drive their execution.
• Support Operations strategic initiatives toward the achievement of the gross margin improvement program, through strong lean management approach across QA and QC (inc. Lean Labs in the QC operations), driven by a focus on proactive risk management and ICH principles.
• Ensures continuous improvement of the QMS at the sites.
• Foster the continuous improvement of the Quality culture in the organization.
• Lead an efficient Quality and manufacturing sites network, compliant with cGXP requirements of global regulatory agencies (FDA, EMA, ANVISA, MHRA, EAEU GMP, etc) and the Teva Quality Management System related to the development, manufacturing, packaging, testing, release and distribution of active pharmaceutical ingredients.
• Ensure the implementation and continuous improvement of the Teva Quality Management System at site level to ensure compliance with existing and evolving guidelines, to increase the efficiency of the quality processes and quality systems and to identify and execute corrective and preventive actions, where applicable to close gaps.
• Drive standardization and harmonization of best practices across the sites.
• Ensure sites inspection readiness, inspection management and in case of inspection observations, implementation of corrective and preventive actions in a timely manner meeting agencies expectation. Ensure that sufficient resources are made available.
• Ensure a strong deviation investigation management system is established and executed on site level, that identifies and investigates quality deviations to root cause, defines appropriate CAPAs, ensures CAPA effectiveness and timely reporting in accordance with regulatory requirements.
• Support direct handling and resolution of severe quality incidents.
• Foster the identification of best practices and state-of-the art technologies.…