Senior IT Compliance Specialist

TN Italy; Monza; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking an IT Compliance Specialist to join their dynamic team. In this role, you will be the key contact ensuring operational compliance of IT systems, collaborating with global teams to align IT processes, and supporting audit readiness. Your expertise in GxP regulations and IT controls will drive the execution of projects while maintaining compliance with industry standards. This is a fantastic opportunity to develop your career in a supportive environment that values innovation and collaboration, making a significant impact on technology solutions in a fast-paced setting.

Competenze

• 3+ years of relevant IT experience in compliance roles.
• Experience with EDMS and QMS systems, including writing changes and CAPAs.

Mansioni

• Ensure operational compliance of IT and support site audit readiness.
• Collaborate with global teams to develop and implement IT processes.

Conoscenze

IT Compliance

GxP Regulations

Analytical Skills

Problem-Solving

Communication Skills

Project Management

Formazione

Bachelor's Degree in IT or related field

Strumenti

EDMS

QMS Systems

GAMP5

Descrizione del lavoro

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As a member of the PSG IT Core Services Team delivering solutions & support in partnership with local and global functions, we will provide operational compliance and technical support to the site, driving efficient and compliant technology solutions.

What will you do?

• Be the key contact to ensure operational compliance of IT.
• Collaborate with global teams to align, develop, and implement IT processes, policies, procedures, and documentation to meet industry standards, regulatory, business, and quality requirements.
• Support IT functions by identifying issues/risks, performing gap analysis, planning, and monitoring corrective actions.
• Act as the IT point of contact (POC) supporting project activities conducted by the CSV team and for new manufacturing lines, digital performance management, Industry (Rockwell Factory Talk).
• Ensure IT systems are maintained in GxP validated states for their intended purpose.
• Drive the execution of smaller projects within scope, budget, and schedule by developing and completing project documentation to support business requirements, technology needs, and regulations.
• Support site audit readiness, regulatory inspections, and client audits.
• Assist in crafting and handling deviations, CAPAs, and Change Controls.
• Maintain and perform periodic user reviews of main IT systems, updates, and refresh IT operating procedures in collaboration with IT technical/application groups, CSV, and quality teams.
• Guide periodic discussions on IT internal metrics sharing and Key Performance Indicator monitoring.

How will you get here?

Education and Experience:

• 3+ years of relevant IT-related work experience.
• Previous experience in an IT compliance role.
• Experience working onsite providing technical support in a customer-facing environment.
• Experience working with EDMS and QMS systems, including writing changes, deviations, and CAPAs.
• Experience in writing test plans, designs, business processes, requirements, and technical specifications.
• Experience collaborating with IT colleagues across various geographies and disciplines.

Knowledge, Skills, Abilities

• Solid understanding of IT Controls, GAMP5, GxP regulations, CSV, SDLC, Data Integrity, Part 11, Annex 11, and relevant standards.
• Strong analytical, prioritization, problem-solving, time management, and organizational skills.
• Excellent written, verbal communication, and interpersonal skills for effective collaboration with multi-functional global/local teams and end-users.
• Ability to manage customer and supplier relationships.
• Flexibility to balance and prioritize multiple tasks.
• Drive and eagerness to learn and develop both technical and functional skills.
• ITIL Foundations Certification is a plus.

Our 4i Values:

As part of a team of over 125,000 colleagues, we share core values — Integrity, Intensity, Innovation, and Involvement — working together to accelerate research, address complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

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. Join us.