Associate Director IT Quality and Compliance

2 giorni fa

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

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.

About the Role:
  • Ensure that GxP computerized systems and infrastructure are implemented and maintained 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 that can mitigate gaps.
  • Deliver training programs to TAPI computerized systems owners.
  • Support sites with any IT-related projects as required.
  • Support sites with computer systems validation, infrastructure qualification, and systems life cycle management, together with any remediation needed.
  • 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 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 environment.
  • Advanced knowledge and experience in problem-solving.
  • Advanced communication skills – written and verbal.
  • Advanced agility leadership and teamwork skills.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
  • Recognition and rewards for outstanding performance.
How to Apply:

If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and cover letter, to [insert contact information]. We look forward to hearing from you

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