Compliance Specialist III

Who are we?

If you’re like people at Teva, you dare to be different. We’re making well-being a way of life for our customers and our colleagues. Join us in helping to make healthcare more accessible to more patients while supporting one of the most innovative teams in the industry.

Teva’s Salt Lake City, Utah production site (s) are two of our complex manufacturing and supply chain operations. Our East site is located at our facility in Research Park, near the University of Utah (Address: 577 Chipeta Way, Salt Lake City, Utah. 84108) & our West Site is located near Salt Lake City International Airport (Address: 4745 Wiley Post Way, Salt Lake City, Utah. 84116).

We are strengthening and adding to our critical teams with great talent and capabilities: Teva, a global organization with a brand of evolving success. Be part of it!

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

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 have 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!

Job Description

This position will be responsible for Quality Compliance Knowledge Management, Site Inspection Readiness program and related activities, compliance related internal/external Partner activities and for negotiation and maintenance of Partner Quality Technical Agreements (QTAs). This position will interact directly with Partners and Regulatory as required or as directed by the department manager and support Regulatory Agency Inspections, Teva Global Regulatory Audits (GRA), internal audits and Partner audits and for the development and monitoring of corrective action plans related to trends identified from inspection and audit observations.

ESSENTIAL AREAS OF RESPONSIBILITY

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Responsible for ensuring effective processes are in place to prepare for and support Regulatory inspections, Teva GRA audits, and internal/external Partner audits.
• Responsible for participating in preparations for and supporting inspections/audits as needed.
• Responsible for Knowledge Management communicated from Global and Segment Quality or Compliance covering all areas of applicability (i.e. pharmaceuticals, biologics, devices, combination products).
• Responsible for reviewing and evaluating regulatory and quality compliance requirements, inspection outcomes, and Global Notifications to Management to ensure site compliance and mitigate risk.
• Responsible to ensure performance and completion of gap assessments and periodic reviews (i.e. corporate standards, Global Compliance trends, SOP reviews) to assure compliance by the site.
• Responsible for Assessment of the Regulatory Compliance status of the site with implementation of CAPA to assure Inspection Readiness compliance.
• Responsible for management and execution of the site Inspection Readiness Dashboard to ensure all areas of the dashboard which are applicable to the site are inspection ready.
• Responsible for negotiations, review and approval of Quality Technical Agreements with stakeholders.
• Responsible for managing special projects that require cross-functional teams, benchmarking and presentations to senior management to assist in decision making.

Responsible for performing additional related duties as assigned.

Qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Bachelor’s Degree, preferably in a scientific or engineering discipline, or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical or related industry.
• Strongly prefer a minimum 3 years performing audits and measurements of GMP Quality Systems, preferably in the pharmaceutical industry.
• Requires experience and knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Working knowledge of FDA, EMA, DEA, EPA and other regulatory requirements for a research and commercial environment.
• Experience providing support for regulatory agency inspections preferred.
• Experience with writing and negotiating Quality Technical Agreements preferred.
• Experience in a pharmaceutical manufacturing environment preferred.
• ASQ CQE/CQA Certification (or equivalent) preferred.

Function

Sub Function

Reports To

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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

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