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Senior Director, Nonclinical R&D Quality

Date: Feb 12, 2019

Location: West Chester, Pennsylvania, US, 19380

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

Position Summary:   

This position is filled by a professional who, as a result of education and in-depth regulatory experience in pharmaceutical Quality Assurance –Good Laboratory Practice (GLP), possesses the advanced knowledge and skills necessary to provide expert management and guidance in the area of  Good Laboratory Practice regulations and clinical bioanalytical analysis requirements; applies strategic thinking and risk management in setting standards to assure the quality, accuracy, and integrity of data in regulatory submissions; applies excellent communication skills within a collaborative environment on cross-functional and cross-cultural teams with a commitment to continuous quality improvement.

 

Travel Requirements:   

Up to 10% travel may be required

 

Essential Duties & Responsibilities

  • Establish, direct, and execute the global GLP program that is consistent with relevant regulatory authority regulations, requirements, and guidance documents
  • Develop a global strategy for Nonclinical R&D Quality to ensure harmonized and efficient processes
  • Develop and execute relevant corporate standards
  • Serve as a company-wide expert in national and international Good Laboratory Practice regulations in order to assure the appropriate interpretation and application of GLP regulations to procedures and processes
  • Lead multidisciplinary projects or initiatives that establish global policies related to Good Laboratory Practice
  • Lead the conduct and follow-up of external inspections by regulatory authorities related to GLP and clinical bioanalysis
  • Manage staff located on local and global teams
  • Participate as a subject matter expert on external industry working groups related to GLP
  • Participate as a member of Global R&D Quality Management team
  • Follow Teva Safety, Health and Environmental policies and procedures
  • Complete other projects and duties as required/assigned

 

 

Qualifications

Education Required:  Minimum of BA/BS Degree in a relevant field

 

Experience Required:  15+ years of relevant experience in the pharmaceutical, biotechnology, or medical device industry

 

Function

Quality

Sub Function

R&D Quality

Reports To

Vice President, Quality R+D

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.


Nearest Major Market: Philadelphia