Senior Compliance Specialist

🔥 0 minutes ago

🌐 United Kingdom, Czechia, +4 more countries – Remote

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⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Manage all aspects of GxP regulatory authority inspections at CRG, investigator sites, and clients • Provide consultation to project teams and clients on GxP inspection readiness, preparation, management, and follow-up • Serve as the primary point of contact for client inspection-related discussions • Support inspections through risk assessment and mitigation, staff training, mock interviews, internal preparation, pre-inspection activities, documentation review, hosting, facilitation, and post-inspection follow-up • Support investigation of non-conformance root causes and development of CAPAs • Follow up on action implementation, effectiveness checks, and supporting evidence collection and review • Contribute to lessons-learned discussions and company-wide improvement initiatives • Mentor and guide junior colleagues • Focus primarily on EMEA while supporting inspections in other regions

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of quality assurance experience, or equivalent combination of education, training, and experience • Extensive knowledge of GxP, with GCP required • Strong understanding of applicable regional research regulations and guidelines • Experience managing GxP inspections, with 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 • Ability to multitask, prioritize complex demands/workload, and remain flexible • Veeva QMS and auditing experience a plus

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Meaningful work contributing to scientific excellence and global health, cleanliness, and safety • Passionate, innovative workplace

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