Regulatory Compliance Senior Manager - Parsippany, NJ

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

Job Description

The primary purpose of the Regulatory Compliance Senior Manager is to 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, Field Alert Reports, Biological Product Deviation Reports, Medical Device Reports, Illegitimate products reporting, Drug Shortage Reporting, Recalls 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.

 

• Responsible to 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, compile, and resolve suggestions/comments.
• Work with Regional FDA District Recall Coordinator to coordinate the FDA’s review of the Recall Letter.
• Utilize the Enterprise Resource Planning System to identify remaining inventory within Teva Control as well as all customers to whom product was distributed to.
• 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.
• Monitor the Notification to Management and Potential Alerts for potential notifications to FDA of any potential Field Alert Reports, Biological Product Deviation Reports, Medical Device Reports, Illegitimate products reporting, Drug Shortage Reporting and Recalls.   
• Liaison with the Teva Quality sites located outside of the USA for filing any of the reports with FDA on a timely manner.
• Perform activities necessary to communicate specific Drug Shortage events and periodic updates to FDA Drug Shortage Staff (FDA DSS). Work with Commercial Marketing and Supply Chain on obtaining information for periodic updates to FDA.
• Provide weekly updates to FDA DSS, respond to request for information by FDA DSS and update the FDA DSS Drug Shortage Webpage on a biweekly basis based on information obtained from the Supply Chain and Commercial. Keep management informed of critical potential supply interruptions that could affect the Company reputation. 
• Work with various Quality Systems and Regulatory Compliance Process Owners to ensure North Wales/Parsippany site 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, daily summary notes, etc.
• Provide Regulatory Agency Inspection support to Teva sites who supply products to USA market.  

Your experience and qualifications

• Bachelor's Degree in a scientific discipline
• A minimum of 7 years of Quality/Compliance related experience in the Pharmaceutical (or related) industries
• Functional knowledge concerning Pharmaceutical Quality Assurance, Quality Control and Regulatory Compliance 
• Excellent GMP knowledge
• Strong knowledge of Excel; knowledge of TrackWise, Veeva, and/or SAP is a plus
• Excellent written communication skills
• Teamwork and negotiation skills
• Ability to professionally and successfully interact with all levels of management
• Ability to work un-supervised
• Ability to juggle, correctly prioritize and advance multiple activities and projects simultaneously

Enjoy a more rewarding choice

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, 13 paid Holidays