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Associate Director IT Quality and Compliance

2 mesi fa

Rho, Lombardia, Italia Tevapharm A tempo pieno
About the Role

We are seeking an experienced Associate Director IT Quality and Compliance to join our team at Teva Pharmaceuticals. As a key member of our IT organization, you will be responsible for ensuring that our computerized systems and infrastructure are managed in accordance with our policies, standards, and procedures.

Key Responsibilities
  • Manage the implementation and maintenance of GxP computerized systems and infrastructure in accordance with TAPI policies, standards, and procedures.
  • 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 TAPI Sites IT and IT QA on inspections trends, observations, authorities' expectations, and best practices to mitigate gaps.
  • Deliver training programs to TAPI computerized systems owners.
  • Support sites with any IT-related projects as required.
  • Conduct GxP computerized systems gap assessments/evaluations with applicable regulations.
Requirements
  • Bachelor's degree in Engineering, Computer Science, Science, or other related field.
  • Minimum of 10 years of experience in 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.
  • 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 environment.
  • 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.