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Associate Director, Quality Compliance

Date: Nov 25, 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

The incumbent will serve as the Global Business Owner for Corporate Quality Standards relating to Product Complaint Trending, Signal Detection Quality Investigations, and Notifications to Management (NTM). This person will also serve as the primary liaison with Pharmacovigilance related to Quality’s role and interactions in Pharmacovigilance processes such as signal detection and PSURs.  The incumbent will prepare periodic summary reports, ad-hoc reports, facilitate meetings, and assist sites in trend investigations as necessary.

 

•   Owner of certain Corporate Quality Standards (Complaint Trending, NTM, QAM/MACs)
•    Assists the Senior Director of Global Quality Operations Compliance in review of Corporate Standards for implementation.
•    Attends Quality Alignment Meetings (QAM)/ Market Action Committee (MAC) meetings
•    Member of the global Trackwise User Advisory Board.
•    Support Quality Risk Management group with Vendor Alerts and Critical Vendor Incident reporting.
•    Product Complaint Trending
•    Supports the Global Quality Complaints Program during Regulatory Authority inspections.
•    Compiles and provides quality complaint data AdHoc for the Quality Global Monthly Report
•    Publishes the Global Quality Quarterly Trend Report.
•    Reviews product quality complaint trend and adverse event signal investigations.
•    Chairs the Quarterly AE-PC Joint Global Trend & Safety Signal Review Meeting.
•    Chairs the Annual Signal Detection Meeting and Publishes the Annual Signal Detection Report.
•    Facilitates the on-time completion of Quality Signal Detection Investigations.
•    Manage two Quality professionals that perform related activities
•    Support Quality Services & Improvement with periodic analysis of NtM and Recall data for Quality Councils, TEC, and QLT meetings.
•    Other duties as required by the business or assigned by management.

Qualifications

  • Bachelor of Science is required
  • Minimum 8 years management level experience in a pharmaceutical industry or related industry is required
  • Extensive knowledge of cGMP requirements is required
  • Technical experience from working at a manufacturing facility with the ability to understand and interpret regulatory requirements is required
  • In-depth knowledge of pharmaceutical quality and quality systems, with broad experience and exposure to best practices is required
  • Experience in statistical trending of product quality complaints and adverse event signals
  • Extensive knowledge of the Trackwise software application is preferred
  • Experience in a Regional and/or global role is preferred
  • Effective and persuasive communication, internally and externally Skilled in computer software using programs such as Excel (including Pivot Tables), WORD, PowerPoint, MS Project, Trackwise, SharePoint, Statistical Trend Analysis software, etc.

Function

Quality

Sub Function

Quality Compliance

Reports To

Sr Dir, Global Quality Systems Management, Quality Management (US Quality)

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