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Quality Systems & Regulatory Compliance Manager

Date: Dec 4, 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 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 Commercial Marketing on obtaining information for periodic updates to FDA
  • Conduct the applicability and gap assessment for the CORP STDs for the Quality Systems & 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 Alert and Recalls coordination in a large pharma/FDA regulated environment.  Drug Shortage experience is desirable
  • Strong working knowledge of CFRs and cGMPs
  • Experience with any of the following is desirable—TrackWise, SAP, Oracle
  • Strong verbal and written communication skills are a must

 

 

Function

Quality

Sub Function

Commercial Quality

Reports To

Associate Director, Quality Systems and Regulatory Compliance--USA

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