Senior Compliance Specialist – EMEA

About the role

Thermo Fisher Scientific is seeking a Senior Compliance Specialist to lead GxP regulatory authority inspections across the EMEA region. You will work closely with project teams and clients to ensure inspection readiness and drive continuous improvement in quality systems.

Key responsibilities

• Provide consultation on GxP inspection preparation, execution, and follow‑up.
• Act as primary contact for inspection discussions with clients and regulatory bodies.
• Support inspections of CRG, investigator sites, and sponsors, including risk assessment, staff training, mock interviews, and documentation review.
• Investigate root causes of non‑conformances, develop CAPAs, and monitor their effectiveness.
• Mentor junior colleagues and contribute to company‑wide improvement initiatives.

Required profile

• Bachelor’s degree or equivalent with 5+ years of quality assurance experience.
• Extensive knowledge of GxP, mandatory GCP experience, and familiarity with regional research regulations.
• Proven ability to manage complex inspection projects and conduct root‑cause analysis.

Required skills

• GCP inspection management
• Veeva QMS
• Auditing
• Risk assessment and impact analysis
• Root‑cause analysis

What we offer

• Opportunity to work on global, high‑impact projects.
• Collaborative environment that values innovation and scientific excellence.
• Professional development and mentorship programs.