Director, Global Quality Compliance TORCH
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Teva Pharmaceuticals is the world’s leading manufacturer of generic medicines, proud producer of many products on the World Health Organization’s Essential Medicines List. Together we are on a mission to make good health more affordable and accessible to millions around the world.
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 team. This highly experienced quality, compliance and operations leader will drive the activities of the TORCH team, partnering 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 Teva Global Operations modernization projects, inspection readiness, inspection support and follow-up.
Location:
Any Teva TGO (Teva Global Operations) location in Europe.
Travel:
Up to 50% international travel expected.
- 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, etc.
- Inspection readiness & inspection management including preparation of subject matter experts, coaching, shop floor Gemba, back‑room strategy, site remediation and investigative protocols, inspection response co‑writing & review, and CAPA effectiveness monitoring and verification.
- Product quality incident management oversight and monitoring.
- Lead multi‑cross site investigations.
- Provide guidance to ensure compliance with Teva’s global standards, regulatory guidelines, and cGMP requirements.
- Support/lead Global Quality Compliance Initiatives; 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 utilizing robust root cause analysis tools with appropriate CAPA.
- Review inspection readiness dashboards, self‑audit program schedules, trends/signals, and CAPA effectiveness for critical supply sites.
- Assist with Health Authority inspection support, preparing inspection responses, post‑inspection support and monitoring commitments.
- Collaborate with site compliance teams to perform floor and laboratory walk‑throughs.
- Work with sites to ensure mock audits meet their needs and verify inspection readiness.
- Write or execute protocols for deep‑dive quality compliance assessments, conduct risk assessments, evaluate justification positions, support storyboards, and prep SMEs.
- Create and monitor Quality Improvement Plans (QIP) to minimize quality compliance risk and improve performance.
- Ensure effective Quality Risk Management to assess, control, communicate, and review risks.
- Contribute to Teva’s Global Compliance Network, addressing and advising GxP regulation interpretation, corporate standards, lessons learned, knowledge management, and evolving regulation.
- Bachelor’s Degree in chemistry, microbiology, pharmacy, engineering, or a related science‑based degree.
- 12+ years of experience as a functional leader with technical, team management, and operational responsibility.
- Ability to work with various organizational leadership levels and in a team environment across multiple roles, with multi‑cultural competence.
- Excellent experience in compliance and Health Authority interaction, leading inspection readiness activities and programs, compliance team leadership or quality unit leadership, successful outcomes delivered through a variety of global regulatory inspections, product submissions,…
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