Senior Compliance Specialist - EMEA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

• 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.

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 5+ years of quality assurance experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.

• Extensive knowledge of GxP, with GCP required, along with a strong understanding of applicable regional research regulations and guidelines.
• Experience with management of GxP inspections (GCP inspection experience mandatory)
• Excellent oral and written communication skills
• Strong problem solving, critical thinking, risk assessment and impact analysis abilities
• Confirmed experience in root cause analysis
• Flexible and able to multi-task and prioritize complex demands/workload
• Veeva QMS and auditing experience a plus

• Exposure to electrical office equipment.

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

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