Senior IT Governance Specialist

7 giorni fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

As a vital member of the PSG IT Core Services Team, you will play a key role in delivering solutions and support in collaboration with both local and global functions. Your focus will be on ensuring operational compliance and providing technical assistance to facilitate efficient and compliant technology solutions.

Key Responsibilities:

  • Act as the primary contact for maintaining operational compliance within IT.
  • Work alongside global teams to align, develop, and implement IT processes, policies, procedures, and documentation that adhere to industry standards, regulatory, business, and quality requirements.
  • Assist IT functions in identifying issues and risks, conducting gap analyses, and formulating, defining, and monitoring corrective action plans.
  • Serve as the IT point of contact for project activities led by the CSV team, including new manufacturing lines and digital performance management initiatives.
  • Ensure that IT systems are sustained in a GxP validated state for their intended use.
  • Lead the execution of smaller projects within defined scope, budget, and timeline by developing and completing necessary project documentation to support business needs, technology requirements, and regulatory compliance.
  • Prepare for site audit readiness and regulatory inspections, including client audits.
  • Assist in the development and management of deviations, CAPAs, and Change Controls.
  • Conduct periodic user reviews of primary IT systems and collaborate with IT technical/application groups, CSV, and quality teams to update and refresh IT operating procedures.
  • Facilitate discussions on IT internal metrics and monitor Key Performance Indicators.

Qualifications:

  • Bachelor's degree in computer science or a related field is preferred.
  • A minimum of 3 years of relevant experience in IT.
  • Prior experience in an IT compliance role is essential.
  • Experience in customer-facing technical support roles is advantageous.
  • Familiarity with EDMS and QMS systems, including writing changes, deviations, and CAPAs.
  • Proficient in writing test plans, designs, business processes, requirements, and technical specifications.
  • Experience collaborating with IT colleagues across diverse geographies and disciplines.

Skills and Abilities:

  • Strong understanding of IT Controls, GAMP5, GxP regulations, CSV, SDLC, Data Integrity, Part 11, Annex 11, and relevant standards.
  • Excellent analytical, prioritization, problem-solving, time management, and organizational skills.
  • Outstanding written and verbal communication skills, with the ability to effectively collaborate with multi-functional global and local teams.
  • Proven ability to manage customer and supplier relationships.
  • Demonstrated flexibility in balancing and prioritizing multiple tasks.
  • A drive and eagerness to learn and enhance both technical and functional skills.
  • ITIL Foundations Certification is a plus.

Our Values:

At Thermo Fisher Scientific, we are united by our core values of Integrity, Intensity, Innovation, and Involvement. Together, we work to accelerate research, tackle complex scientific challenges, drive technological innovation, and support patients in need. We value diverse experiences, backgrounds, and perspectives.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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