Senior Manager EMSO Quality

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

The role is accountable to ensure deliverance of revenue and free cash flow for complex products (including combination products) within the EMSO Americas division, including committed Customer Service Levels and On-Time In-Full (OTIF) targets, while ensuring compliance targets. They are accountable to manage the quality activities for the device components, drug components and finished products produced by Teva’s Third Party external manufacturing and packaging partners. They are accountable to ensure the product meets established standards of quality including reliability, usability, and performance. Ensures ongoing compliance with quality and industry regulatory requirements for 21CFR 820 and 21CFR Part 4, as well as 21CFR Parts 210/211.

How you’ll spend your day

• Collaborate with suppliers to ensure their compliance and the quality of their products, materials, components and/or operations. 
• Analysis and development of specifications and test methods with both external and internal business partners (change controls, release documents, and other applicable documentation) to confirm and sustain compliance to 21 CFR Parts 4, 210 and 211.
• 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. 
• Manage product quality complaint investigations and determine if regulatory notification (ex. FAR or BPDR) is required. 
• Development and presentation of product data to management in support of changes. Maintenance of product files. 
• Participate in Quality Councils and Management Review for SRT, including tracking and managing actions for Complex products. 
• Manage KPIs and prepare presentations for Complex meetings as required. 
• Visit CMOs to resolve critical issues, including audits of products. 
• Receive and review quality customer complaint investigations, nonconformance reports and laboratory investigations, ensuring all necessary components are included.  
• Ensure annual stability testing is being performed as per regulatory requirements. 
• Compile data from third party suppliers for the preparation of annual product review. 
• Participate in root cause analysis and prepare written investigations for deviations/NCRs. Follows up with suppliers on quality deviations and ensures solutions are identified and implemented, including those from supplier audits. 
• Attend all daily/weekly operational and quality meetings in support of Complex products. 
• Development of processes and procedures to support QMS. 
   

Your experience and qualifications

• Bachelor’s degree in Science or Engineering with a minimum of ten (10) years’ experience in aseptic processing and/or combination products.
• Must have in-depth knowledge of the QSR CFR Part 820, Part 4, and ISO13485 & 14971 regulations, and desired experience with CFR Part 210/211, ICH and applicable international regulations/guidelines.
• Experience with investigations, change controls, product release, validation, CAPA, is required. 
• Strong technical writing skills. 
• Ability to resolve complex problems and contribute to improvements and solutions. 
• Experience with Quality Systems such as electronic deviations (ex. Trackwise) and documentation management systems, SAP, and serialization.
• Experience with external pharmaceutical manufacturing, packaging, testing and release is desired.
• Strong computer skills including TrackWise, Oracle and SAP is desired.
• Ability to set appropriately set priorities and work independently with minimal guidance. 

Key Competencies

• Quality: attention to detail and accuracy, committed to excellence, suggests improvements to existing process, identifies root causes, owns and acts on quality issues.
• Integrity/Ethics: Deals with others in a straightforward and honest manner, is accountable for own actions, maintains confidentiality and supports company values.
• Teamwork: meets all team deadlines and responsibilities, listens and values other’s opini