1+ months

VP Quality Compliance

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!
Job Description

 

The VP Global Quality Compliance provides leadership and strategic direction for all Quality compliance related matters coming from the Teva network and the contract manufacturing and supplier network, ensuring the evolution of the TEVA Quality Management System and the Quality IT infrastructure, along with business continuity and consistency in the interaction with regulatory authorities.  He/she reports to the SVP Quality and EHS&S / CQO, and is a member of the Global Quality Leadership team.  Specific responsibilities include:

 

  • Design and maintain a compliant & efficient Quality Management System (QMS); maintaining Tevas license to operate and driving continuous improvement throughout the product lifecycle and across the organization 
  • Lead a strategic risk management plan by scrutinizing the external regulatory environment, analyzing trends in regulations and providing recommendations through the QMS, in collaboration with peers
  • Ensure inspection readiness of all sites in the Teva production network, the R&D units and clinical centers, the distribution centers and commercial quality units, using data analytics to identify signals for compliance risks 
  • Manage and continuously improve the site risk matrix in the compliance risk space
  • Ensures the management infrastructure and processes are in place for sites, Technologies, TPO (Third Party Operations), Commercial Quality and Global Quality to perform respective Quality Councils and their continuous improvements in a harmonized way, with specific ownership of the Global Quality Council
  • Expand audit focus to identify high risk/low maturity sites and suppliers.  Establish plans, in conjunction with Quality Operational Leads of Technologies/TPO/Commercial Quality, to remediate high risk (low maturity) sites and vendors
  • Establish a formal inspection readiness program.  Provide inspection support to sites before, during and after inspections.  Apply Quality Oversight over regulatory responses and corrective and preventive actions and their effectiveness.  Establish feedback loops to share and train upon knowledge gained 
  • Enhance the Supplier Quality program, in partnership with Procurement, to further define vendor selection, qualification and disqualification processes
  • Development and deployment of Global Quality Commercial Units and post marketing monitoring and operations in the different markets, understanding the product behaviour and performance. Ensuring products are efficiently and well-distributed

 

Qualifications

 

  • Senior Leadership experience in Quality and operations (15+ years)
  • Communication skills across several hierarchical layers including Senior Executives
  • Ability to lead, program manage and remediate during Crisis management
  • Planning and organizing, strategic thinking, people development and organizational influence
  • Deep understanding and strong connections to the Health Authorities across the globe, (not only FDA)
  • Prudent risk taking using risk management principles and data analyses
  • Significant, direct interaction with world-wide health authorities
  • Quality Leadership positions should have been successfully fulfilled along with direct Operational experience
  • Direct "hands-on" experience leading complex remediation efforts (e.g. Warning  Letters and preferably Consent Decree) for multiple Health Authorities
  • Deep/thorough knowledge of global regulations (impacting Teva's business) with the ability to interpret and apply those requirements
  • Technical knowledge sufficient to make decisions on product recalls
  • Thorough knowledge and understanding in Quality and operation processes along the entire business value chain
  • Willingness and ability to travel up to 50% including international
Function
Quality
Sub Function
Quality Assurance Methods
Reports To

SVP Quality and EHS&S

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Categories

Posted: 2020-06-01 Expires: 2020-08-28

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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VP Quality Compliance

Teva Pharmaceuticals
Parsippany, NJ 07054

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