Teva Quality Manager 

United States, New Jersey 

640449559

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.

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.
  

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