Senior Quality Assurance Specialist - External Manufacturing

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

Are you ready to make a difference in global health and quality of life for patients worldwide? We are seeking a highly skilled and motivated Senior Quality Assurance Specialist to join our team and ensure the quality and compliance of our critical and unique drugs and combination products, Including Creams, Ointments, Suspensions, Patches, Suppositories, and Sublingual films. As the Senior Quality Assurance Specialist, you will collaborate with external manufacturing and packaging partners within the Liquids, Creams, and Ointments Supplier Relationship Team (SRT) to ensure all products meet established quality standards. Your key responsibilities will include ongoing compliance with quality and regulatory requirements, supplier quality oversight, and monitoring of supplier KPIs to drive improvements in performance.

You will be responsible for ensuring the release of high-quality products manufactured and/or packaged at Teva's Third Party Suppliers, and for reviewing and approving change controls and validation protocols and reports. You will also act as the primary contact for various cross-functional teams involving product transfers, new product launches, and supply chain activities. We are looking for someone who can resolve complex problems, work independently with minimal guidance, and has strong technical writing and computer skills including TrackWise, Excel, and SAP. If you are passionate about improving global health and are committed to ensuring the quality of critical and unique drugs and combination products, we want to hear from you!

How you’ll spend your day

Key Responsibilities:

• Collaborate with suppliers to ensure the quality of their products, materials, components, and/or operations, and monitor supplier KPIs to support efforts to develop and implement improvements to performance.
• Follow up with suppliers on quality deviations and ensure that solutions are identified and implemented, including conducting supplier audits.
• Provide Quality oversight for all manufacturing, packaging, and testing at Teva’s Third Party Suppliers, and assure ongoing compliance with quality and industry regulatory requirements for cGMPs, 21CFR 210/211, 21CFR 820, and 21CFR Part 4.
• Receive, review Quality Customer Complaint investigations, non-conformance reports, and laboratory investigations, ensuring all necessary components are included.
• Review, evaluate and approve change controls from Third Party Suppliers and act as the point of contact for all comments between internal departments and the site.
• Communicate critical issues that may impact the product on the market or product intended for the commercial market to senior-level management.
• Review and approve validation protocols and reports for activities occurring at Third Party Suppliers.
• Represent the EMSO Quality department and act as the primary contact for various cross functional teams involving product transfers, new product launches, supply chain activities, etc.
• Provide training, support, and guidance to other Quality Analysts.

Your experience and qualifications

• 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.
• Minimum of 8+ years' experience in a pharmaceutical FDA regulated industry in Quality Assurance or related field.
• Knowledge of cGMPs, CFR, ICH, and applicable international regulations/guidelines.
• Experience with investigations, change controls, product release, CAPA, validations is required.
• Experience with external pharmaceutical manufacturing, packaging, and testing is desired.
• Able to resolve complex problems and contribute to process improvements.
• Works independently with minimal guidance.
• Strong technical writing skills.
• Strong computer skills including TrackWise, Excel, and SAP are desired.

Enjoy a more rewarding choice

While we take great pride in helping millions around the world enjoy healthier lives every day, looking after our people is our pr