Compliance Manager

đŸ”„ 1 hour ago

đŸ‡Ș🇾 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 1 hour ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

đŸ„ Healthcare

Biotechnology ‱ Pharmaceuticals ‱ Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

‱ Conduct complex internal and/or external audits for compliance with quality assurance processes, standards, global regulatory guidelines, and client contractual obligations ‱ Identify issues affecting the quality or integrity of clinical research programs ‱ Determine root causes of non-conformance and develop strategies to address issues ‱ Perform technical document reviews and other GxP activities supporting clinical development programs ‱ Provide audit reports to management ‱ Plan and deliver quality services for contracted quality assurance audits, internal site audits, laboratory audits, and file audits ‱ Lead process and quality improvement initiatives ‱ Develop tools and materials for tracking compliance management activities and analyze trends ‱ Mentor less experienced staff ‱ Serve as project lead for group projects ‱ Create formal networks with key contacts across the department

🎯 Requirements

‱ Bachelor’s degree in life sciences, nursing, pharmacy, or related field ‱ 5+ years of clinical research experience, including at least 2 years in Clinical Quality, GCP Compliance, or related role ‱ Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA expectations ‱ Proven experience in CAPA, root cause analysis, and deviation management ‱ Ability to communicate complex compliance issues clearly and effectively ‱ Comfortable working in a matrix organization and managing cross-functional customers ‱ Thorough knowledge of applicable GxP and regional regulations ‱ Extensive knowledge of the clinical trial process ‱ Excellent oral and written communication skills, including medical and scientific terminology ‱ Training and mentoring experience ‱ Strong attention to detail ‱ Ability to work independently or in a team environment ‱ Highly developed problem-solving, risk assessment, and impact analysis abilities ‱ Strong leadership skills ‱ Strong organizational and time management skills, including multitasking and prioritization ‱ Strong digital literacy and ability to learn appropriate software ‱ Flexibility and adaptability ‱ Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel ‱ Prior experience with clinical quality systems such as Veeva Vault or TrackWise is a plus ‱ Veeva QMS experience is a plus ‱ Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered

đŸ–ïž Benefits

‱ Fully remote work arrangement ‱ Global team environment ‱ Collaboration and professional development opportunities ‱ Corporate credit card with sufficient credit line for business travel

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