Teva Associate Director EMSO Quality 

United States, New Jersey 

233262993

is accountable to ensure deliverance of revenue and free cash flow for a key and critical combination 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 manage the quality activities for the device components, drug components and finished products produced by Teva’s Third Party external manufacturing and packaging partners for this key product. 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.

• Provide quality and compliance support to SRT and CMOs in support of products.
• Review and approve documentation in partnership with internal business partners and external business partners (change controls, non-conformances, release documents, and other applicable documentation) to confirm and sustain compliance to 21 CFR Part 4.
• Participate in root cause analysis and prepare written investigations for deviations.
• 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.
• Responsible for preparation of documentation for shipment and release of materials and components as well as finished products.
• Actively participates in the maintenance of the TPO Quality Management System (QMS) in support of products.
• Participate in Quality Councils and Management Review for SRT, including tracking and managing actions for products.
• Manage KPIs for epinephrine products and prepare presentations for meetings as required.
• 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 on CMP audits and ensure solutions are identified and implemented.

• Bachelor’s degree in Science or Engineering with a minimum of ten (10) years’ experience in the medical device, combination products or pharmaceutical field required.
• 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 devices is desired.
• Strong computer skills including TrackWise, Oracle and SAP is desired.
• Ability to appropriately set priorities and work independently with minimal guidance.

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