We Are Teva

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 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 andothers. 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 UK, Ireland, Germany or Italy. Other Teva locations across Europe also may be considered.

Location

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

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; forexample: 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 matterexperts, 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 cGMPrequirements. Foster and Promote Communication, Harmonization, and Support across supplyoperations.
• Support/lead Global Quality Compliance Initiatives, i.e. develop and contribute to Teva’s Long Range Planand Global Quality Compliance Initiatives.
• Support critical product incident management events; may include complex investigations at the sitesensuring comprehensive, scientific, well-written investigations utilize robust root cause analysis tools withappropriate CAPA to prevent regulator enforcement actions whereby mitigating risk to Teva.
• With respect to quality compliance derisking activities, for critical supply sites, review inspection readinessdashboard and self-audit program schedule, trends/signals, and CAPA effectiveness verifying state ofcompliance.
• 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 andlaboratory 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 riskassessments, 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 qualitycompliance risk and improve quality performance and KPI measures.
• Ensure Quality Risk Management is implemented effectively to assess, control, communicate, and reviewrisks.
• Contribute to Teva’s Global Compliance Network: Addresses and advises GxP regulation interpretation,Teva’s Corporate Standards requirements, lessons learned and knowledge management of qualitycompliance 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:

• 10+ 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 multipleroles. 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 tonavigate changing priorities and deliverables, agile and flexible to respond to critical needs of the business, comfortable in working within a matrix environment.

Functional / Industry Knowledge:

• Analytical testing and quality control requirements for the life cycle of solid dosage, biologics, biosimilars, steriles, liquids and/or drug substance essential
• Pharmaceutical Quality Control experience required. Experienced in one or more dosage forms desirable: API, Solids, Medical Device, Sterile, Biologics, Biosimilars.
• Strong practical knowledge in pharmaceutical/device laboratory release and incoming material testing.
• Highly proficient in laboratory investigations including LIR, OOS and Deviations, and how to implement best practices.
• Deep knowledge of current and upcoming pharmacopoeial requirements and current Quality best practices, health regulations and international guidances pertaining to laboratory instruments and test methods.
• Strong knowledge of cGMP requirements for products and process, including stability requirements for development and routine commercial expectations.
• Solid understanding of, and familiarity with the testing requirements for raw materials, packaging materials, in-process controls and release testing for various pharmaceutical dosage and medical device products.
• Strong knowledge of laboratory quality systems, including instrument qualification and data.
• Good working knowledge of analytical instrument software and GMP impacting computer systems; Empower, LIMS and other software platforms typically used by Teva and the requirements for validation

Critical Capabilities

• Resilient and deep drive for continuous improvement and compliance.
• 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.

How We’ll Take Care of You

Reports to

Dir, Global Quality Compliance Lead

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