Associate Director IT Quality and Compliance

23 ore fa

Rho, Lombardia, Italia Tevapharm A tempo pieno
Associate Director IT Quality and Compliance

At Teva Pharmaceuticals, we're committed to making good health more affordable and accessible. As our Associate Director IT Quality and Compliance, you'll play a critical role in ensuring that our computerized systems and infrastructure are managed according to our policies, standards, and procedures.

The Opportunity
  • Develop and maintain effective working relationships with peers within the Teva Quality and IT organization.
  • Ensure that our Quality Management System (QMS) related to GxP Computerized Systems is aligned with current regulations, data integrity principles, industry guidance, and inspection trends.
  • Provide QA IT review and approval on all globally managed Computerized System deliverables.
  • Represent site users as System Business Owner for globally managed Computerized Systems, manage site inspection readiness, and support with regards to globally managed Computerized Systems.
  • Guide Teva Sites IT and IT QA on inspections trends, observations, authorities' expectations, and best practices that can mitigate gaps.
  • Deliver training programs to Teva Computerized Systems owners.
  • Support sites with any IT-related projects as required.
  • Conduct GxP computerized systems gap assessments/evaluations with applicable regulations.
Your Experience, Skills, and Qualifications
  • Bachelor's degree in Engineering, Computer Science, Science, or other related field.
  • Minimum of 10 years of experience and strong overall understanding of Computerized System Validation and quality business processes supporting global functions, manufacturing, and laboratory operations.
  • Working experience in API/Pharma companies in a similar role is a must.
  • Proven management capabilities managing direct and matrix teams and projects.
  • 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.
  • Exposure, working experience, and knowledge of GAMP-5 and SCADA systems.
  • Ability to work with external vendors/suppliers, experience with IT supplier management is desirable.
  • Advanced leadership skills, business strategy, accountability, proven experience leading and motivating global, cross-functional teams.
  • International experience - a must.
  • Advanced experience in working with matrix environments.
  • Advanced knowledge and experience in problem-solving.
  • Advanced communication skills - written and verbal.
  • Advanced agility leadership and teamwork skills.
  • Must be able to travel based on business need; up to 30% when critically required (domestic and international).
  • Fluent in English - a must.

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