Associate Director Global Quality Compliance TORCH (Turbigo)

Associate Director Global Quality Compliance TORCH (Turbigo)

31 lug
|
Teva Pharmaceuticals
|
Turbigo

31 lug

Teva Pharmaceuticals

Turbigo

ppbWe Are Teva /b We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. /p h3The opportunity /h3 pThe 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, RD Quality, Commercial Quality, MST, RD, 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. /p h3Location /h3 pThis role can be based in UK, Ireland, Germany or Italy. Other Teva locations across Europe also may be considered. /p pUp to 50% international travel expected (HQs, internal sites, additional required meetings, etc.). /p h3How You’ll Spend Your Day /h3 ul liAct and behave in accordance with Teva’s values and leadership standards. /li liTargeted support based on critical business needs and potential risks. /li liGlobal 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. /li liInspection 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. /li liProduct quality incident management oversight and monitoring. /li liLeads multi‑cross site investigations. /li liProvide guidance to ensure compliance with Teva's global standards, regulatory guidelines, and cGMP requirements. Foster and Promote Communication, Harmonization, and Support across supply operations. /li liSupport/lead Global Quality Compliance Initiatives, i.e. develop and contribute to Teva’s Long Range Plan and Global Quality Compliance Initiatives. /li liSupport 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 thereby mitigating risk to Teva. /li liWith 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. /li liInspection 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. /li liWhen needed, work collaboratively with the site compliance teams to perform activities such as floor and laboratory walk through. /li liWork 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. /li liWhen 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. /li liHelp create, where needed, review and monitor the Quality Improvement Plans (QIP) to minimize quality compliance risk and improve quality performance and KPI measures. /li liEnsure Quality Risk Management is implemented effectively to assess, control, communicate, and review risks. /li liContribute 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. /li /ul h3Education /h3 ul liBachelor's Degree – chemistry, microbiology, pharmacy, engineering, or related science‑based degree /li /ul h3Experience /h3 ul li10+ years of experience as a functional leader with technical, team management, and operational responsibility. Continuous professional development. /li liAbility 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. /li liExcellent 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. /li liWorking knowledge of audit and inspection management, response writing and investigation, complaint, CAPA management programs required. /li liExcellent 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. /li /ul h3Functional / Industry Knowledge /h3 ul liAnalytical testing and quality control requirements for the life cycle of solid dosage, biologics, biosimilars, steriles,



liquids and/or drug substance essential. /li liPharmaceutical Quality Control experience required. Experienced in one or more dosage forms desirable: API, Solids, Medical Device, Sterile, Biologics, Biosimilars. /li liStrong practical knowledge in pharmaceutical/device laboratory release and incoming material testing. /li liHighly proficient in laboratory investigations including LIR, OOS and Deviations, and how to implement best practices. /li liDeep knowledge of current and upcoming pharmacopoeial requirements and current Quality best practices, health regulations and international guidances pertaining to laboratory instruments and test methods. /li liStrong knowledge of cGMP requirements for products and process, including stability requirements for development and routine commercial expectations. /li liSolid 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. /li liStrong knowledge of laboratory quality systems, including instrument qualification and data. /li liGood 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. /li /ul h3Critical Capabilities /h3 ul liResilient and deep drive for continuous improvement and compliance. /li liEnergetic, committed to continuous improvement and problem‑solving. /li liEffective negotiation skills, strong interpersonal skills, excellent presentation skills. /li liStrong project management, organizational skills to lead a dynamic team and change management. /li liProactive orientation, self‑motivated, flexible, and innovative way of thinking. /li /ul h3How We’ll Take Care Of You /h3 pAt Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one‑stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short‑term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. /p pReports to: Dir, Global Quality Compliance Lead /p h3Teva’s Equal Employment Opportunity Commitment /h3 pTeva 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. /p /p #J-18808-Ljbffr

📌 Associate Director Global Quality Compliance TORCH (Turbigo)
🏢 Teva Pharmaceuticals
📍 Turbigo

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