Teva Director Quality System Compliance 

United States, New Jersey 

741779909

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).

• 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 and implement sustainable Quality System processes, particularly in the following areas: Corporate policies and standards as well as communication systems.
• Create and Implement quality systems that will acquire and analyze data required to manage the Management Review Process and the CAPA process
• Review division requirements and other new regulations in a timely manner, and perform and/or assist system owners by performing gap analysis and revisions to existing systems
• Provide quality / technical expertise and oversight to the activities performed within the department
• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
• Helpdesk site support for questions, copies, interpretation, suggestions, requests for standards.
  

Education:

• Bachelor's Degree – chemistry, microbiology, pharmacy, engineering, or related field.
• Master's Degree preferred – in science, business, healthcare, or an equivalent combination of education and experience related to Quality Assurance/Quality Control - advantage at large and complex sites.

Experience:

• Pharmaceutical Quality Manufacturing experience. Solids, Medical Device, Sterile, Biologics, and/or Biosimilars Quality Compliance experience required.
• Minimum 10 years of experience in Quality or Operations in a GMP environment. Understanding and insight into different aspects of quality functions & associated quality systems in Quality Control, Microbiology, Quality Assurance, Quality Systems, Quality Compliance, Documentation, etc. required.
• Demonstrates continuous professional development.
• Proven leadership skills, ability to lead and motivate global, cross-functional teams.
• Adequate knowledge of local current and upcoming legislation and current Quality best practices required. International experience is an advantage.
• Advanced knowledge in Problem Solving required.
• Advanced experience in working with matrix environment.
• Advanced ability to understand, interpret, and execute in accordance the Teva Quality Management System required.
• Advanced English communication skills – written and verbal required.
• Advanced teamwork skills required.
• Solid knowledge of MRP Systems and GMP impacting computer systems, like SAP, Empower, LIMS and software platforms typically used by Teva preferred.

Specialized or Technical Knowledge Licenses, Certifications needed:

• Project management certification (e.g. PMP) is a plus.
• ASQ certification can be helpful

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