30 days old

Associate Director Third Party (TPO) Quality, Americas

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 Assoc. Director LCO Products, Third Party Operations Quality Americas is accountable to deliver on revenue and free cash flow for a category of products, including committed Customer Service Levels and On-Time In-Full targets, while ensuring compliance targets. Will be accountable for the LCO SRT quality and compliance, and is the Quality decision maker to the SRT. Will lead a team of Quality Analysts/Managers to ensure all drug, combination or device products produced by Tevas Third Party partners, meet the established standards of quality including reliability, usability, and performance. Will ensure ongoing compliance with quality and industry regulatory requirements for cGMPs, 21CFR 210/211, 21CFR 820 and 21CFR Part 4.

 

 Key Quality Responsibilities

 Serve as the Quality Relationship Manager (QRM) for a group of Third Parties. Be the main point of contact with the third party Site Quality Head and sit as the acting team member for Quality on the SRT and be the final decision maker on Quality decisions. Lead and manage Quality meetings for the Category, such as Quality Council

Represent the TPO Quality department and act as the primary contact for various cross functional teams (Supply Chain, MS&T, PM) involving product transfers, new product launches & supply chain activities. Develop and implement Quality KPIs that ensure delivery of performance and sustained compliance for the SRT

Lead a team of Quality Analysts/Mangers for a category of products. Assign and manage Quality activities and ensure team performs product release for US and Global Markets to sustain inventory needed for market.  Mitigate and resolve complex quality issues contributing to back orders, drug shortages, and product launches, including FARs. Manage a budget to ensure compliance to AOP

Development of employee objectives and manage employee development and performance, including planning and reviewing compensation actions, enforcing policies and procedures, and performing performance review sessions. Also responsible for the organizational structure of group, including job descriptions, recruiting, selecting, orienting, and training

Prepare, negotiate and amend new and existing Quality Technical Agreements

Qualifications

Bachelors degree in a Science or Engineering discipline

Minimum of fifteen (15) years of quality assurance experience in a Pharmaceutical FDA regulated industry including medical device experience, analytical lab experience, and external pharmaceutical manufacturing experience 

Minimum five (5) years experience leading a team

Must have working knowledge of cGMPs, CFR (210/211/ 820/4), ICH and applicable international regulations/guidelines.

Must have direct experience with making Recall/FAR decisions and hosting such forums.

Experience with Approving Investigations, Change Controls, Product Release, CAPA, Validations is required as well as hosting Quality Councils.

Strong computer skills including TrackWise, Oracle and SAP is desired

Function

Quality

Sub Function

Supplier Quality

Reports To

Senior Director, Third Party Quality, Americas

Competencies

5. Functional - Key functional requirements set by hiring manager
AC - Analytical Thinking
AC - Agility and resilience
AC - Following Processes & Procedures
AC - Judgement and Decision Making
AC - Problem Solving
Manager Principles - Leading the Way

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.

Categories

Posted: 2021-01-29 Expires: 2021-03-28

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Associate Director Third Party (TPO) Quality, Americas

Teva Pharmaceuticals

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