Quality Manager

Who we are

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!

The opportunity

POSITION SUMMARY
The role is accountable to deliver and responsible to manage the systems, processes, and operations in support of the quality assurance activities for Teva’s drug, biologic, medical device, and combination products produced by Teva’s Third Party External Manufacturing and Supply Operations (EMSO) partners, and ensure they 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.

 

KEY RESPONSIBILITIES

• Assure ongoing compliance with Quality and industry regulatory requirements for cGMPs, 21CFR Parts 210/211, 21CFR Parts 600/610, 21CFR Part 820 and 21CFR Part 4, and other applicable regulations such as ISO and ICH standards.
• Collaborate with Suppliers and Service Providers to assure the quality of their products, materials, components, operations and/or services.
• Monitors Batch Release Cycle Time and supports efforts to develop and implement improvements for performance.
• Follows up with suppliers on quality deviations and ensures that solutions are identified and implemented.  Includes supplier audits.
• Responsible for managing the final release activities of product manufactured and/or packaged at Teva’s EMSO Third Party Suppliers located in the U.S., as well as re-release of products from other regions to the U.S. market.
• Provide Quality oversight for all manufacturing/packaging/testing at Teva’s EMSO Third Party Suppliers.
• Receive and review Quality Customer Complaint investigations, Non-conformance Reports, Deviation Investigations and Laboratory Investigations ensuring all necessary components are included.
• Review, evaluate and approve Change Controls from EMSO Third Party Suppliers and service providers and act as the point of contact for all comments between internal departments and the site.
• Communicate to Senior Level Management any issues that may impact product currently on the market as well as any critical issues that may impact product intended for the commercial market.
• Represent the EMSO NA Quality department and act as the primary contact for various cross functional teams involving supply chain activities.
• Provide training, support, and guidance to EMSO and Quality employees.

Your experience and qualifications

EDUCATION

• Bachelor’s degree in a related scientific or technical discipline.
• Certifications such as Quality Auditor, Quality Engineer, Quality Improvement Associate and/or Six Sigma are a plus. 

EXPERIENCE

• Minimum of 5 years experience in a Pharmaceutical FDA regulated industry in Quality Assurance or related field.
• Must have in-depth knowledge of cGMPs, CFR, ICH and applicable international regulations/guidelines.
• Experience with Investigations, Change Controls, Product Release, CAPA, Validations, required.
• Experience with External (Third Party/Contract) Pharmaceutical manufacturing, packaging, and testing is desired.
• Able to resolve problems and contribute to process improvements.
• Works independently with minimal guidance.
• Strong technical writing skills.
• Strong computer skills including TrackWise, Excel, and SAP is desired.
   

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, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.

Already Working @TEVA?

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