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Sr Mgr, Nitrosamines Investigations Lead

Date: Feb 6, 2021

Location: Netanya, IL, 11111

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

As part of Teva’s Global Nitrosamine Project Team, the Nitrosamines Investigation Lead plays an important role in the oversight of technical activities related to root-cause investigations associated with the management of nitrosamines.  This role will drive interactions across Teva sites and entities in the creation of an integrated Teva technical position on nitrosamine related issues. The incumbent will ensure alignment amongst Teva sites, Segment and Global entities, including a common strategy for managing root cause investigations at Teva sites and CMOs.

Duties and Responsibilities

  • Serve as a liaison between the Nitrosamines Team, manufacturing sites (including Teva Pharma, Teva api and CMOs), and Teva Global functions such as Procurement in the collection and sharing of technical information
  • Ensure site’s conduct technical investigations related to nitrosamines in a standardized way in accordance to plan, employ critical thinking, best compliance practices and apply chemical knowledge to identify root cause for Nitrosamine formation and specify CAPA related to active pharmaceutical ingredient formulation, and/or finished drug product manufacturing control strategy.
  • Monitor execution and assist sites, where applicable, in the creation of comprehensive investigation reports.
  • Where applicable, ensure  creation of broader scope investigation reports across sites and formulations (e.g., at the product family level) that identify common  root causes,
  • Review reports, define a harmonized remediation strategy for Teva, and support regulatory reporting.
  • Develop and maintain an effective management infrastructure.
  • Development and maintenance of tools, procedures and templates that will help sites perform nitrosamines related investigations
  • Create project reporting tools and define metrics related to nitrosamine investigations to ensure effective, routine communication to stakeholders

Qualifications

    • Master’s Degree in Organic Chemistry - must
    • A minimum of 5 years in the pharmaceutical industry is required
    • Experience in project and/or program management leading cross-functional teams
    • Experience in leading investigations at a manufacturing facility
    • In-depth knowledge of pharmaceutical quality and quality systems, especially those related to leading  investigations and CAPAs
    • First experience in a regional and/or global role a plus
    • The ability to effectively communicate both internal and external to Teva; verbal and written communication excellence required
    • The ability to obtain the internal collaboration/input of Teva colleagues, establishing and maintaining sound professional relationships at all levels within the organization
    • The ability to develop practical solutions from complex and diverse information
    • Thinks strategically when developing recommendations and action plans, assessing both the short and long term implications
    • Demonstrates resourcefulness and initiative and creates an appropriate level of urgency to meet objectives and deadlines
    • Computer proficiency including programs such as Excel, Word, PowerPoint and MS Project. 
    • Fluent in English
    • Intercultural competencies

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Global nitrosamines project lead

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Teva’s Equal Employment Opportunity Commitment

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.