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

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. The incumbent is leading TEVA’s offshoring centers for Stability Testing and PQR/APR Compilation.

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

Travel
40 - 50% international travel expected.

How you’ll spend your day

• 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 customers.
• 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.
• Ensure 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. Facilitate and monitor their implementation.
• Develop and lead optimization and efficiency processes.
• Ensure knowledge management across the network, share inspection/audit findings and knowledge to ensure timely site-based assessments and the identification of actions to prevent future or repeat findings.

Oversee the Stability Testing, including:

• Performance of stability tests in TEVA’s offshore-centers (Zagreb, Goa) with registered methods per yearly ongoing stability program (OGS) or after significant changes of the MA (ICH). Ensure that Product Robustness issues are addressed, and the root cause of Compliance issues are identified and remediated.
• Ensure that the necessary AMTs were performed successfully. Ensure that necessary method adoptions/re-developments are initiated, if a certain analytical method is not stability indicating.
• Development and validation of stability indicating Methods as Service provider for TEVA sites or TPO.
• Storage and sampling of stability samples as per stability plan defined by the product owner (e.g. TEVA site).
• Coordination of testing, shipping and storage between the different TEVA Sites, EMSO suppliers and the Offshoring Centers.
• Identify Cost saving opportunities such as reduced testing, and use of Global Business Services (GBS), APRs/PQRs.
• Oversee the delivery of APR/PQRs by ensuring the planning, establishment, and management of work plans, required resources (headcount, expense, and capital) and expected capabilities to meet existing and future business needs.
• Ensure EHS&S mindset across the quality operations and laboratories in the cluster sites, and a proactive risk management approach to safety.
• Lead, mentor, and develop a high-performing global team, promoting collaboration and innovation fostering a culture of accountability, professional growth, & employee engagement.
• Guides team members' professional growth and development and support selection of key quality resources.

Your experience and qualifications

• Minimum of 15 years pharmaceutical manufacturing multiples sites quality operations and leadership experience.
• Direct interaction with health authorities.
• Experience working in a large, complex matrixed environment with global processes & governance structures; practical knowledge of pharmaceuticals manufacturing and/or control.
• Practical knowledge of analytical techniques and microbiological principles practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering).
• Product and technology transfer.

Critical Skills/Capabilities

• Professional
  Practical knowledge of Global Compliance and Regulatory requirements, Industry guidelines (e.g. ICH guidelines specifically M7, PIC/s, PDA), cGxP: Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice and other guidelines, the regulations of supervisory authorities at local and international level, specifically US FDA, EMA, etc.
• Practical knowledge in manufacturing, testing and health authority inspections and expectations for the dosage form in the site network.
• Ability to develop and execute Strategic / Long Range and Annual Business Plans.
• Practical knowledge on risk management.
• OpEx and LMS.

Essential

• Strong critical thinking/problem-solving skills to navigate ambiguous situations; Strategic thinking; Excellent storytelling and presentation skills; Cross-functional collaboration and stakeholder management; Effective communication; Strong relationship and senior stakeholder management capabilities.

Leadership

• Strong leadership, change management & influencing skill; Decision-making under uncertainty skills; Ability to drive transformational change in a large/global/matrixed environment; Proven talent management & people development capabilities (incl. coaching and mentoring); Ability to create an engaging & inclusive work climate and a culture of appreciation and trust; Ability to set a vision and drive organizational change and innovation; Ability to manage effectively complexity within the organization (shifting timelines, projects, priorities).