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Senior Director GLP/GCLP Quality

Date: Nov 25, 2021

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!

 

Teva’s Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.

 

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting onthe first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee StockPurchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

Job Description

This position is filled by a professional who possesses the advanced knowledge and skills necessary to provide expert direction and guidance in the area of  Good Laboratory Practice regulations and clinical bioanalytical analysis (GCLP) requirements in order to assure the quality, accuracy, and integrity of data in regulatory submissions; applies experience and excellent communication skills within a collaborative environment to assure that the GLP/ GCLP  functions are supported with a commitment to continuous quality improvement. 

 

•    Lead the development, management, and improvement of GLP/GCLP  quality systems and procedures to ensure compliance with applicable regulations and company procedures, in support of GLP activities and clinical bioanalysis 
•    Identify compliance risks and recommend solutions and best practices 
•    Establish and sustain a robust Quality Management System (QMS) and Inspection Readiness 
•    Provide expert advice, supervising, mentoring and training for junior auditors for activities that support GLP studies and clinical bioanalysis  
•    Serve as an 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
•    Develop and deliver training programs as required, e.g., GLP, data integrity, inspection readiness, etc.  
•    Maintain up-to-date knowledge of regulatory guidance documents, regulations and trends relative to GLP, GCLP, and data integrity and incorporate into auditing processes
•    Execute critical phase and process-based inspections of GLP studies for compliance with the study protocol, GLP regulations, and SOPs 
•    Execute internal facility inspections of laboratory equipment, personnel, methods, computer systems, facilities and records
•    Conduct final report and data audits to assure the report accurately reflects the raw data and all methods and procedures specified in the protocol and SOPs 
•    Evaluate CAPAs, Deviations, Laboratory Investigations, and protocols for compliance with GLPs/GCLPs and SOPs
•    Perform quality oversight for GLP software validation and related documentation
•    Review standard operating procedures related to GLP and clinical site activities for compliance with regulations, good documentation practices and compatibility to related SOPs
•    Perform inspections of contract research organizations (CROs) used for toxicology studies and preclinical and clinical bioanalysis for compliance with FDA and OECD GLP regulations and relevant guidelines 
•    Develop or revise Nonclinical R&D Quality’s standard operating procedures
•    Assist with or lead the conduct and follow-up of GLP/GCLP external inspections by regulatory authorities  
•    Follow Teva Safety, Health and Environmental policies and procedures
•    Complete other projects and duties as required/assigned
•    Ensure  employee training and qualification

Qualifications

Education Required:  

  • Minimum of BA/BS Degree in a relevant field


Experience Required: 

  • Minimum 15 years of relevant experience in the pharmaceutical, biotechnology, or medical device industry; prior supervisory responsibility experience.
  • Ability to use common software applications (Word, Excel, Power Point) to create required records,  reports, and presentations


Travel Requirements: 

  • 15%-20% travel may be required

Function

Quality

Sub Function

R&D Quality

Reports To

VP, Quality R&D, Quality Compliance Mgmt

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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. 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.


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