Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Recruiting across all EMEA locations

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

As a Senior Compliance Specialist within the Inspections team, you will be responsible for managing all aspects of GxP regulatory authority inspections at CRG, investigator sites, and clients. The majority of the work is focused on the EMEA region; however, inspection support in other regions is also in scope.

What You'll Do:

• Provide consultation to project teams and clients on GxP inspection readiness, preparation, management, and follow-up activities.
• Serve as the primary point of contact for inspection-related discussions with clients.
• Support GxP regulatory authority inspections of CRG, investigator sites, and sponsors, including risk assessment and mitigation strategies, training of involved staff and conducting mock interviews, internal preparation, pre-inspection / mock inspection activities, review of documentation requested by inspectors, inspection hosting and facilitation, and post-inspection follow-up.
• Support project teams in investigating root causes of non-conformances and in developing CAPAs to address identified issues; follow up on action implementation, effectiveness checks, and the collection and review of supporting evidence.
• Contribute to lessons learned discussions and participate in company-wide improvement initiatives.
• Provide mentorship and guidance to junior colleagues.