1+ months

Senior Director, Third Party Quality, Americas Region

Parsippany, NJ 07054

Company Info

 

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've 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! 

We offer a complete 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.

 

 

 

 

Job Description

 

This position directs the Quality function for the Third Party Quality operations in the Americas Region (US and Canada). The activities include :

  • The quality oversight of the contract organizations that manufacture, package and test products on the behalf of Teva for commercial products marketed in the US and Canada.
  • Define and shape supplier quality management strategy and relationships through collaboration with suppliers and other functional managers.
  • Proactively manage and improve supplier quality performance. The incumbent will be the primary liason for the Americas Region with the Vice President of Third Party Operations for the Americas.
  • Provide direct accountability of the TPO Quality function in the Americas to the Global TPO Quality function while having matrix reporting and accountability to Third Party Operations for the Americas.
  • Manage a team of Quality Relationship Managers (QRMs), in partnership with Supplier Relationship Managers (SRMs), to ensure reliable supply of quality products.
  • Manage and ensure compliance with all applicable Quality Technical Agreements (QTAs).
  • As a member of the TPO leadership team for the Americas, support and execute the defined strategy as outlined by Third Party Operations and Global Third Party Quality.
  • Effectively and compliantly manage all aspects of Quality Systems for Third Party, both internally and externally with our suppliers.
  • Develop and execute operational budgets and ensure alignment with Goals and Objectives of Technical Global Operations and Third Party Operations.
  • Effectively execute and manage risk to support customer service targets while sustaining quality and compliance in all operational aspects.
  • The incumbent will serve as the Management Representative for the combination products in accordance with 21 CFR 820.20.b.3.
  • Ensure that critical incident management processes are efficiently and effectively performed such that appropriate decisions are made and required actions are taken for high risk quality and compliance events that impact marketed products, including Event Recognition, Field Alert Reports and Market Action decisions.
  • Ensures the Product Quality Complaint management processes are in place and effectively performed such that the investigation and associated responses to complainants are completed in a timely and compliant manner.
  • Ensure that regulatory inspections and Internal Audits of the Quality, Regulatory, Complaint, Product Disposition and any / all related Quality Systems are properly managed and responded to in a timely manner.
  • Assure that appropriate metrics are generated to enable continuous performance improvements for the department and assist the business in making informed decisions.

Qualifications

 

Education

  • Bachelors Degree in a related scientific or technical discipline preferred, e.g., Pharmacy, Chemistry, Biology, Chemical Engineering
  • Masters degree in a scientific or business discipline preferred

 

Key Requirements

  • Minimum 15 years of progressively increasing experience in Pharmaceuticals/Pharmaceutical Quality Assurance related positions
  • Previous experience with cGMPs, GLPs, GDPs, Quality Policies, Complaints, Stability Programs, Deviation Investigations, Laboratory Investigations, Root Cause Analysis, CAPA, Audits, and FDA Inspections are a must
  • Significant experience at a pharmaceutical/biopharmaceutical/medical device manufacturing/ packaging/ testing facility
  • Experience with manufacturing, packaging and laboratory testing of different dosage forms
  • Experience with  FDA and Health Canada regulations
  • Strong written, verbal communication, and platform skills
  • Experience leading and developing a team of Quality professionals
  • Ability to travel up to 35% domestically and as required to support critical Third Party Quality business needs

 

Function

Quality

Sub Function

Supplier Quality

Reports To

Vice President, Third Party Quality, Global

Tevas Equal Employment Opportunity Commitment

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.

Categories

Posted: 2019-04-17 Expires: 2019-09-15

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Senior Director, Third Party Quality, Americas Region

Teva Pharmaceuticals
Parsippany, NJ 07054

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