Clinical Compliance Manager

🔥 16 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 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

• Develop and execute quality and compliance strategies and initiatives across the organization • Promote awareness of quality and regulatory compliance standards, industry trends, and best practices • Lead quality and compliance initiatives ensuring clinical processes comply with GxP regulations, company standards, and client requirements • Serve as a GxP subject matter expert and support risk assessment and mitigation activities • Develop, maintain, and improve QMS documentation, policies, procedures, guidance documents, and training materials • Drive continuous improvement initiatives to strengthen quality systems and operational efficiency • Create and maintain compliance tools, dashboards, and quality metric reports • Conduct complex internal and external audits and inspections • Support regulatory inspections, client audits, and investigative site audits • Perform technical document reviews and other GxP quality activities for clinical development programs • Investigate quality issues and non-conformances, perform root cause analysis, and implement corrective and preventive actions • Oversee governance and compliance management processes • Collaborate across departments to promote best practices and build quality partnerships • Mentor and coach junior auditors and quality professionals • Build relationships with internal stakeholders and designated client quality teams

🎯 Requirements

• Bachelor's degree or an equivalent combination of education, training, and relevant experience • 8+ years of experience in clinical quality, regulatory compliance, clinical research, or a related field • Strong knowledge of GxP regulations and the end-to-end clinical trial process • Extensive experience with Quality Management Systems (QMS), SOPs, and regulatory inspections • Excellent verbal and written communication skills, including the ability to communicate scientific and technical information effectively • Demonstrated experience leading audits and mentoring or training team members • Strong analytical, problem-solving, risk assessment, and decision-making skills • Excellent organizational, prioritization, and project management abilities • Proven ability to build collaborative relationships and influence stakeholders across functions • Proficiency with Microsoft Office and quality management systems, with the ability to quickly learn new technologies • Flexibility to travel as business needs require

🏖️ Benefits

• Opportunities to grow your career • Professional development through mentoring and coaching • Collaboration with talented colleagues • Meaningful scientific advancement work • Environment valuing innovation, integrity, and continuous learning

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