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Global Clinical Quality Compliance Manager

Date: Nov 18, 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 on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance.

Job Description

In this role you will champion and drive activities in support of the Quality (Good Clinical Practice, GCP) Management System for GCQ incorporating Risk Management principles along with Specialty Clinical Development and Generics Clinical R&D. You will work independently with minimal guidance to solve complex problems and take a new prospecting using existing solutions


Essential Job Duties and Responsibilities:

•    Lead Quality Event and CAPA investigations by providing thorough, complete and timely investigations, impact assessment and Corrective/Preventative Actions
•    Involvement in Inspection Readiness, Inspection Management and responses
•    Audit vendor, investigator site or other sites as applicable 
•    Successfully facilitate, communicate and implement process design and/or improvement when needed

Qualifications

•    Minimum Bachelor’s of Science from an accredited university or college
•    Minimum 7 years of working knowledge in GxP and experience in GCPs/FDA/ICH/EU directives
•    Minimum 7 years auditing experience 
•    Experience in conducting Quality Event/CAPA investigations 
•    Experience in Inspection Readiness and Inspection Management 

Additional Preferred Qualifications:
•    Minimum 7 years conducting Quality Event/CAPA/Investigations demonstrating thorough, complete and timely reports containing root cause, impact assessment, CAPA and effectiveness checks. 
•    Minimum 7 years experience in Inspection Readiness and Inspection Management in a pharmaceutical setting where at least 2 inspections occurred while employed. 

Function

Quality

Sub Function

R&D Quality

Reports To

Director, Quality, Generic R&D Quality (US)

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.


Nearest Major Market: Philadelphia