Director, Quality System Compliance

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 Director of Global Quality Systems Compliance plays a critical role in overseeing and continuously improving quality processes across Teva Global Operation (TGO) to advance compliance, efficiency, and customer experience.

 

The Director will also be responsible for:

• ensuring that our products, processes, and Quality Systems are in compliance with regulations and Teva policies. 
• ensuring that Teva’s quality system (e.g. CAPA, management review, design control, non-conformances, FCAs, change control) produces products and processes that conform to defined requirements.
• participation in key global projects that provide quality acceleration, ensuring the overall strategy for advance compliance and capture changes in regulations. 
• global compliance quality oversight and governance in strong collaboration with manufacturing operations to ensure excellence in inspection readiness and successful inspection management at critical internal and external supply sites.
• taking an active part in the Veeva Quality Vault project, specifically in the area of the Electronic Document Management System (EDMS).

 

Location: This is a hybrid position that can sit out of our Parsippany, NJ or West Chester, PA offices.

 

Travel: Must be able to travel based on business need; up to 40% when critically required (domestic and international)

How you’ll spend your day

• Leadership and Oversight:
  • Overseeing and continuously maintaining TGO Quality Corporate Standards and Policies to advance compliance and capture changes in regulations.
  • Collaborating with regional and site-specific teams to track, report, and present updates in Teva Quality System.
  • Monitoring the effectiveness of the Quality system and providing reports to executive management.
  • Defining vision and executing strategy for continued compliance and increased efficiency of Quality Management Systems, including improved investigations processes, CAPA effectiveness, etc.
  • Overseeing and continuously leading improvement in quality processes across TGO to advance compliance, efficiency, and customer experience.
  • Acting as a business leader and taking an active part in the Veeva Quality Vault project, specifically in the area of the Electronic Document Management System (EDMS). Leading Quality compliance initiatives/projects for Quality System 2.0.
  • Providing standards overview and training locally based on site requests.
• Quality System Management and Oversight:
  • Drafting, revising, managing distribution, archiving, and lifecycle approvals of Quality Corporate Standards  and Policies, including maintenance of guidance for SmarTeam.
  • Driving gap assessments - corporate standards vs new guidance, corporate standards vs Teva site BoH observations, corporate standards vs other firms’ observations.
• Continuous Improvement:
  • Implementing best practices for enhanced efficiency and effectiveness.
  • Tracking regulatory trends and providing guidance on expected changes affecting existing and future strategies.
  • Leading Cross-Functional Collaboration such as SME’s groups for sharing best practices, new regulations updates, improvement to standards, etc.
  • Quality Plan development/tracking as required.
  • Tracking regulatory commitments, creating Investigator Database.
  • Supporting weekly Quality Portal updating.
  • Initiating and maintaining site directory for quality management to be updated monthly.
  • Providing Inlet air/other engineering quality guidance
  • Collaborate with Quality Assurance, Regulatory Affairs, Research and Development, and other relevant departments.
  • Provide on-site support as per company needs in remediation, hands-on with Teva sites, supporting Quality Improvement Program activities , remediation efforts, and regulatory inspections both on-site and remotely. 
  • Business leader for Veeva project –play critical role part in the project team and support deployment in later stage of the project.
• Create an