Associate Director, Global Quality Compliance TORCH

Associate Director, Global Quality Compliance TORCH

Location:

Runcorn, United Kingdom, WA7 3FA

Job

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.

Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The main purpose of this role is to act as a subject matter expert and compliance leader in the newly-formed Teva Operations Regulatory Compliance Hyper support (TORCH) internal and external manufacturing teams. This highly experienced quality, compliance and operations leader will be responsible for driving the activities of the TORCH team who collectively partner with TGO site leaders in Quality, Compliance and Operations to ensure proper quality compliance risk identification and mitigation of patient product supply risks, problem solving quality-related issues, vital Pivot to Growth transformation and TGO modernization projects, inspection readiness, inspection support and follow-up.

This role will interact across the TGO network supply sites working with our internal Manufacturing Sites, External Manufacturing Quality, R&D Quality, Commercial Quality, MS&T, R&D, Supply Chain Operations, Procurement, Regulatory, Pharmacovigilance, Medical and others. In some instances, this role will entail global compliance quality oversight and governance in strong collaboration with manufacturing operations to ensure excellence in inspection readiness and successful inspection management at critical internal and external supply sites.

This role can be based in any Teva TGO (Teva Global Operations) Location in Europe.

Up to 50% international travel expected (HQs, internal sites, additional required meetings, etc.)

• Act and behave in accordance with Teva’s values and leadership standards.
• Targeted support based on critical business needs and potential risks.
• Global Projects improving patient supply and quality compliance of our sites, processes, and systems; for example: inspection management and readiness programs, significant event scoping and resolution, deviation quality compliance derisking, building a strong partnership with operations and training of SMEs to ensure successful regulatory inspections, a mature Quality and Compliance mindset and culture of Quality.
• Inspection readiness & inspection management include, but not limited to preparation of subject matter experts, coaching, shop floor Gemba, back-room strategy, site remediation and investigative protocols, inspection response co-writing & review, and CAPA / CAPA effectiveness monitoring and verification.
• Product quality incident management oversight and monitoring.
• Leads multi-cross site investigations.
• Provide guidance to ensure compliance with Teva's global standards, regulatory guidelines, and cGMP requirements. Foster and Promote Communication, Harmonization, and Support across supply operations.
• Support/lead Global Quality Compliance Initiatives, i.e. develop and contribute to Teva’s Long Range Plan and Global Quality Compliance Initiatives.
• Support critical product incident management events; may include complex investigations at the sites ensuring comprehensive, scientific, well‑written investigations utilize robust root cause analysis tools with appropriate CAPA to prevent regulator enforcement actions whereby mitigating risk to Teva.
• With respect to quality compliance derisking activities, for critical supply sites, review inspection readiness dashboard and self‑audit program schedule, trends/signals, and CAPA effectiveness verifying state of compliance.
• Inspection Management Support for Health Authority…