1+ months

Quality Contract Manufacturing Operations (CMO) Manager

Parsippany, NJ 07054
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

The role is accountable to ensure deliverance of revenue and free cash flow for products within the TPO Americas division, including committed Customer Service Levels and On-Time In-Full (OTIF) targets, while ensuring compliance targets. They are accountable to deliver systems, processes, and operations to manage drug, biologic, combination or device products produced by Tevas Third Party external manufacturing and packaging partners, which meet established standards of quality including reliability, usability, and performance. Ensures ongoing compliance with quality and industry regulatory requirements for cGMPs, 21CFR 210/211, 21CFR 820 and 21CFR Part 4.

  • Develop/Enhance, define, and implement systems and processes that deliver compliant, safe, and effective products such as Product Release. Identify and lead projects for continuous improvements and efficiencies, and implements changes to deliver on compliance and savings.
  • Develop, define, and implement Quality KPIs that measure, analyze, and continuously improve the delivery of compliant, safe, and effective products at the SRT level.
  • Host and manage Quality Councils and Management Review for SRT, including tracking and managing actions.
  • Manage the Product Quality Customer Complaint investigation process for SRT, including approval of complaints.
  • Manage Analytical support to SRT including Method Transfers and OOS support. Ensures the implementation of approved release and shelf life specifications and all corresponding methods by CMO and if needed Teva Laboratories. Ensure the compliance of methods to GMP standards and the dossier.
Qualifications
  • Bachelors degree in Science or Engineering with a minimum of ten (10) years experience in a Pharmaceutical FDA regulated industry in Quality Assurance or related field.
  • 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.
  • Analytical Lab experience and 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
Supplier Quality
Reports To

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.

Categories

Posted: 2020-06-01 Expires: 2020-07-18

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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Quality Contract Manufacturing Operations (CMO) Manager

Teva Pharmaceuticals
Parsippany, NJ 07054

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