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Associate Director, Third Party Operations (TPO) Quality--USA

Date: Dec 7, 2018

Location: Parsippany, New Jersey, US, 07054

Company: Teva Pharmaceutical Industries Ltd.

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

Position Summary

You will lead a small team of senior level Quality Analysts and Managers to ensure all drug, biologic, combination or device products produced by Teva’s Third Party external manufacturing and packaging partners meets the established standards of quality including reliability, usability and performance. You will assure ongoing compliance with quality and industry regulatory requirements for cGMPs, 21CFR 210/211, 21CFR 820 and 21CFR Part 4.

Key Responsibilities

  • Lead a team that performs product release for US and Global Markets to sustain inventory needed for market.  Assure appropriate resolution of complex quality issues that could lead to or have contributed to back orders, drug shortages, product launches.
  • Communicate/escalate issues to senior management arising from projects, audits, and/or site meetings that may prevent product release/launch
  • Evaluate Standards and Regulations against local SOPs to identify and eliminate gaps in policies.
  • Reports Quality data including those for key performance indicators (KPIs).
  • Prepare, negotiate and amend new and existing Quality Technical Agreements.
  • Analyze data to identify areas for improvement and/or trends in the Quality System and recommends/implements effective CAPA.
  • Execute quality procedures relative to validations, batch record review, change controls, complaints, deviations, annual product reviews and field alerts.
  • Identify training needs, quality position skill inventories and organize training interventions to meet quality standards.
  • Communicate Management objectives to local team and assure goals are aligned to meet those objectives.
  • Contributes to quality assurance financial objectives by providing information for budgeting purposes.
  • Stay current by studying trends in and developments in quality management, participating in educational opportunities, reading professional publications, maintaining personal networks, and participating in professional organizations.
  • Enhances department and organization reputation by accepting ownership for accomplishing new and different requests.

Qualifications

 Education

  • Bachelor’s degree in a related  technical or scientific discipline
  • Certifications such as Quality Auditor, Quality Engineer, Quality Improvement Associate Quality Control and Compendial knowledge and/or Six Sigma are a plus

 

 

Experience

  • Minimum 8 years related Quality Assurance experience in a Pharmaceutical FDA regulated environment  
  • Minimum 5 years experience leading a quality assurance team
  • Strong working knowledge of cGMPs, CFR, ICH and applicable international regulations/guidelines.
  • Experience with Investigations, Change Controls, Product Release, CAPA, Validations is required.
  • Experience with external pharmaceutical manufacturing, packaging, testing and devices is desired.
  • Strong computer skills including TrackWise, Oracle and SAP is desired.

 

Function

Quality

Sub Function

Supplier Quality

Reports To

Senior Director, Quality- Third Party Operations (TPO)

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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: New York City
Nearest Secondary Market: Newark