1+ months

Associate Director, TPO Quality Systems & Compliance

Parsippany, NJ 07054
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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

You will ensure deliverance of revenue and free cash flow for products, including committed Customer Service Levels and On-Time In-Full targets, while ensuring compliance targets. You will manage a team that deliver systems, processes, and operations to manage drug, biologic, combination or device products produced by Third Party external manufacturing and packaging partners. You will ensure ongoing compliance with quality and industry regulatory requirements for cGMPs, 21CFR 210/211, 21CFR 820 and 21CFR Part 4.

 

Key Responsibilities

  • Implement systems and processes that deliver compliant, safe, and effective products. Identify and lead projects for continuous improvements and efficiencies, and implements changes to deliver on compliance and savings
  • Implement Quality KPIs that measure, analyze, and continuously improve the delivery of compliant, safe, and effective products
  • Host and manage Quality Councils and Management Review
  • Manage a team that support Quality Systems and Compliance, Analytical, and Complaints. Assign and manage activities and a budget to ensure compliance
  • Responsible for the development of objectives and employee development and performance, including planning and reviewing compensation actions, enforcing policies and procedures, and performing performance review sessions
  • Responsible for job descriptions, recruiting, selecting, orienting, and training, of new employees
  • Evaluate Standards and Regulations against local SOPs to identify and eliminate gaps in policies

 

Qualifications

Bachelors degree in a Science or Engineering discipline

  • Minimum of 15 years experience in a Pharmaceutical FDA regulated industry in Quality Assurance and Compliance 
  • Minimum 5 years experience leading a team
  • Must have working knowledge of cGMPs, CFR (210/211/ 820/4), ICH and applicable international regulations/guidelines.
  • Experience with Quality Systems such as electronic deviation and documentation management systems, SAP, and serialization as well as hosting Quality Councils and Management Review is required
  • Analytical Lab experience required
  • Experience with external pharmaceutical manufacturing, packaging, testing and devices is desired
  • Experience with sterile products and devices desired
  • Strong computer skills including TrackWise, Oracle and SAP is desired
Function
Quality
Sub Function
Quality Compliance
Reports To

Senior Director, Third Party 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.

Posted: 2020-07-21 Expires: 2020-10-25

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, TPO Quality Systems & Compliance

Teva Pharmaceuticals
Parsippany, NJ 07054

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