Sr Director, Global IT Quality 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

This role is part of the global Quality Compliance leadership team guiding CSV Quality Compliance within Teva.  Within this role, the leader establishes and maintains effective working relationships with peers within the Global Quality Compliance organization, Teva Global Operations Compliance segments, IT TGO Quality and Compliance and executive stakeholders in both the Quality and IT organizations. The Computerized Systems Governance organization provides oversight and monitoring to ensure that teams delivering and maintaining GxP computerized systems are doing so in accordance with Teva policy, standards and procedures.

The Senior Director IT Quality Compliance leads the organization to ensure computerized systems used in support of GxP processes are effective and managed in compliance with current regulations.  This position is accountable to ensure the Teva QMS for Computerized System Validation (CSV) used in the delivery of GxP computerized systems is in alignment with current regulations, Data Integrity principles, industry guidance and inspection trends.  This leader manages the global Computerized Systems Governance team that maintains CSV governance, regulatory oversight of the IT organization, inspection and audit support to Teva’s sites and ensures consistent inspection readiness is maintained at all times.

 

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

How you’ll spend your day

• Accountable for developing the compliance strategy, short- and long-range plans for the Global Computerized Systems Governance organization
• Liaise with TGO Global Quality, site, IT and business stakeholders 
• Continuously improve the policy, standards, procedures, tools and training related to cGxP CSV ensuring alignment with regulations (Eudralex Annex-11 and 21 CFR Part-11), industry guidance, inspection trends and current Data Integrity guidance
• Fulfill the role of CSV/Data Integrity subject matter expert and ensure current best practices are exercised in support of global GxP computerized systems
• Institute and deliver monitoring program measuring adherence to current CSV practices within the global IT organization
• Provide site and global resources with CSV and DI consultation to supplant skill gaps
• Provide on-site CSV inspection readiness support before and during regulatory inspections
• Deliver training programs for IT, Quality and site-based resources to improve CSV skills, provide education related to inspection trends and generate awareness of the importance of CSV and Data Integrity
• Architect, govern and manage IT infrastructure qualification aligned with current industry regulations, inspection trends, best practices and guidance
• Ensure Data Privacy regulations are incorporated into the Computerized System landscape
• Provide business ownership of IT based GxP computerized system tools such as IT change management, test management, identity management etc.
• Responsible for computerized system quality for the serialization and aggregation programs
• Afford CSV Quality subject matter expertise and consultative services to the various Teva business segments such as Commercial, TGO, R&D, Clinical and Teva API etc.

Your experience and qualifications

Qualifications

• Bachelor’s degree in computer science, science or related field (advanced degree a plus)
• Minimum 15 years of experience and strong overall understanding of Computerized System Validation and quality business processes supporting global functions, manufacturing and laboratory operations
• Prior experience managing direct and matrix teams/projects is required.
• Demonstrated leader in CSV governance
• Strong understanding of regulations and industry standards such as 21 CFR Part-11, Eudralex Annex-11, GAMP 5, Data Integrity regulatory and industry Guidance and proven ability to pragmatically apply these regulations to operate in an efficient and effective fashion.
• Must have international experience

 

Practical Knowledge a