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Manager, Quality Professional

Date: Oct 13, 2021

Location: Parsippany, New Jersey, US, 07054

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!

 

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. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

Job Description

You will perform various Quality/Compliance related activities for the Teva USA Quality Systems and Regulatory Compliance Department as well as support all manufacturing sites that provide products to the USA Market. This includes but is not limited to being responsible for processing and driving to closure the various Notifications to Management Reports, Field Alert Reports, Recalls, Drug Shortage Reporting and process the Corporate Quality Standards to provide assurance that Teva remains compliant with all GMP related Regulations and maintains an excellent quality and compliance reputation in the industry.

Key Responsibilities:
•    Will execute the formal market action decision as dictated by Senior Quality Unit Management and the Market Action Committee and author Product Recall Letter.
•    Circulate draft Recall Letter to Quality Unit Management for review and compile and resolve suggestions/comments.
•    Work with Regional FDA District Recall Coordinator to coordinate the FDA’s review of the Recall Letter.
•    Send Recall Letters to all Customers and applicable Business Partners
•    Liaison with Teva’s Contracted Recall Service Provider to ensure proper handling, reconciliation, and destruction of products returned for a recall event.
•    Ensure Recall Effectiveness Checks are performed.
•    Report Monthly Recall Progress information to the FDA. Submit information for closure of the Recall to FDA.
•    Perform activities necessary to communicate specific Drug Shortage events and periodic updates to FDA Drug Shortage Staff.
•    Work with Supply Chain and Commercial Marketing on obtaining information for periodic updates to FDA
•    Initiate and submit Field Alert Reports to FDA on behalf of some manufacturing sites. 
•    Conduct the applicability and gap assessment for the Corporate Standards for the Commercial Quality Regulatory Compliance Dept. 
•    Author new/enhance existing SOPs to close gaps by the Effective Date of the CORP STD.
•    Work with various Quality Systems and Regulatory Compliance Process Owners to ensure sites are Inspection Ready.
•    Provide support to Inspection related activities including but not limited to: Scribing Notes from Inspection conversations, performing Back Room coordination activities, retrieving/reviewing requested records, and daily summary notes.
•    Provide Regulatory Agency Inspection support to Teva sites who supply products to USA market.

Qualifications

Education:

  • Bachelors degree in a related scientific or technical discipline


Experience:

  • Minimum 7 years related quality/compliance experience including field alerts/product recalls/drug shortage reporting in a large pharma/FDA regulated environment.
  • Product Recall experience required; drug shortage and/or field alert experience are desirable
  • Strong working knowledge of CFRs and cGMPs
  • Experience with any of the following is desirable: TrackWise and SAP

Function

Quality

Sub Function

Commercial Quality

Reports To

Associate Director, Quality Systems and Regulatory Compliance, USA

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: New York City
Nearest Secondary Market: Newark