
10,000+ employees
đ§Ź Biotechnology
đ Pharmaceuticals
đ„ Healthcare
Biotechnology âą Pharmaceuticals âą 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 lifeâsciences 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 massâspectrometry 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.
đ„ 1 hour ago
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

10,000+ employees
đ§Ź Biotechnology
đ Pharmaceuticals
đ„ Healthcare
Biotechnology âą Pharmaceuticals âą 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 lifeâsciences 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 massâspectrometry 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.
âą Conduct complex internal and/or external audits for compliance with quality assurance processes, standards, global regulatory guidelines, and client contractual obligations âą Identify issues affecting the quality or integrity of clinical research programs âą Determine root causes of non-conformance and develop strategies to address issues âą Perform technical document reviews and other GxP activities supporting clinical development programs âą Provide audit reports to management âą Plan and deliver quality services for contracted quality assurance audits, internal site audits, laboratory audits, and file audits âą Lead process and quality improvement initiatives âą Develop tools and materials for tracking compliance management activities and analyze trends âą Mentor less experienced staff âą Serve as project lead for group projects âą Create formal networks with key contacts across the department
âą Bachelorâs degree in life sciences, nursing, pharmacy, or related field âą 5+ years of clinical research experience, including at least 2 years in Clinical Quality, GCP Compliance, or related role âą Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA expectations âą Proven experience in CAPA, root cause analysis, and deviation management âą Ability to communicate complex compliance issues clearly and effectively âą Comfortable working in a matrix organization and managing cross-functional customers âą Thorough knowledge of applicable GxP and regional regulations âą Extensive knowledge of the clinical trial process âą Excellent oral and written communication skills, including medical and scientific terminology âą Training and mentoring experience âą Strong attention to detail âą Ability to work independently or in a team environment âą Highly developed problem-solving, risk assessment, and impact analysis abilities âą Strong leadership skills âą Strong organizational and time management skills, including multitasking and prioritization âą Strong digital literacy and ability to learn appropriate software âą Flexibility and adaptability âą Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel âą Prior experience with clinical quality systems such as Veeva Vault or TrackWise is a plus âą Veeva QMS experience is a plus âą Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
âą Fully remote work arrangement âą Global team environment âą Collaboration and professional development opportunities âą Corporate credit card with sufficient credit line for business travel
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