Clinical Compliance Manager

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🕒 January 28

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

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

• Lead the assessment and classification of serious breaches in collaboration with QA, Clinical Operations, and Regulatory Affairs. • Serve as the primary point of contact for serious breach investigations. • Prepare and submit serious breach notifications to applicable regulatory authorities within required timelines. • Develop and maintain standard operating procedures (SOPs) related to breach management. • Ensure timely and thorough root cause analysis and CAPA development, working closely with functional area leads. • Maintain breach documentation and logs in compliance with GCP and inspection expectations. • Support audits and regulatory inspections as a subject matter expert (SME) for serious breach. • Deliver training and guidance to study teams and sites on breach awareness and reporting procedures. • Trend and report breach data to identify process improvements or systemic quality issues.

🎯 Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field. • 5+ years of clinical research experience, with at least 2 years in Clinical Quality, GCP Compliance, or related role. • Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA serious breach expectations. • Proven experience in CAPA, root cause analysis, and deviation management. • Demonstrated ability to communicate complex compliance issues clearly and effectively. • Comfortable working in a matrix organization and managing cross-functional customers. • Prior experience with clinical quality systems (e.g., Veeva Vault, TrackWise, etc.) is a plus.

🏖️ Benefits

• Flexible work arrangements