Who we are
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 opportunity
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 Hypersupport (TORCH) internal and External manufacturing team. 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 Teva Global Operations (TGO’s) 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..
Location
This role can be based in any Teva TGO (Teva Global Operations) Location
How you’ll spend your day
* 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 Inspections: may include evaluation, guidance, and support for successful Health Authority inspections such as preparation of inspection responses, post inspection support and monitoring of commitments.
* When needed, work collaboratively with the site compliance teams to perform activities such as floor and laboratory walk through.
* Work with sites to ensure mock audits of manufacturing, packaging, laboratory processes, procedures, and facilities meet their needs and verify a state of inspection readiness at the site.
* When needed, write or execute protocol for deep dive quality compliance assessments, conduct risk assessments, evaluate justification positions, support storyboards and prep SMEs for those incidents.
* Help create, where needed, review and monitor the Quality Improvement Plans (QIP) to minimize quality compliance risk and improve quality performance and KPI measures.
* Ensure Quality Risk Management is implemented effectively to assess, control, communicate, and review risks.
* Contribute to Teva’s Global Compliance Network: Addresses and advises GxP regulation interpretation, Teva’s Corporate Standards requirements, lessons learned and knowledge management of quality compliance events, risks, and practices as well as evolving regulation.
Your experience and qualifications
Education:
* Bachelor's Degree – chemistry, microbiology, pharmacy, engineering, or related science-based degree.
Experience
* 12+ years of experience as a functional leader with technical, team management, and operational responsibility. Continuous professional development.
* Ability to work with various organizational leadership levels and in a team environment across multiple roles. Multi and Intercultural sensibility is a key consideration supporting global operations.
* 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 roles in global regulatory inspections, successful product submissions and approvals, lifecycle management.
* Working knowledge of audit and inspection management, response writing and investigation, complaint, CAPA management programs required.
* Excellent interpersonal skills to collaborate across many levels and functions within Teva, ability to navigate changing priorities and deliverables, agile and flexible to respond to critical needs of the business, comfortable in working within a matrix environment.
* Auditing, quality engineering / opex, regulatory affairs, investigation certifications desired
Functional / Industry Knowledge
* Pharmaceutical Quality Manufacturing experience. Solids, Medical Device, Sterile, Biologics, Biosimilars Quality Compliance experience required.
* Strong practical knowledge pharmaceuticals manufacturing, contamination control, facility design, utilities, maintenance, and calibration.
* Adequate knowledge of local current and upcoming legislation and current Quality best practices, health regulations and guidances also essential. International experience is an advantage.
* Strong knowledge of cGMP requirements for products and process.
* Solid understanding and insight into the different aspects of quality functions like Quality Control, Microbiology, Quality Assurance, Quality Systems, Quality Compliance, Documentation, etc.
* Strong knowledge of quality systems.
* Solid ability to understand, interpret, and execute in accordance the Teva Quality Management System.
* Solid knowledge of MRP Systems and GMP impacting computer systems, like SAP, Empower, LIMS and software platforms typically used by Teva.
* Deep knowledge and experience in Auditing, Compliance and Quality Oversight
Critical Capabilities
* Solid knowledge in Problem Solving
* Energetic, committed to continuous improvement and problem-solving.
* Effective negotiation skills, strong interpersonal skills, excellent presentation skills.
* Strong project management, organizational skills to lead a dynamic team and change management.
* Proactive orientation, self-motivated, flexible, and innovative way of thinking.
Reports To
Head of TORCH
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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.