QA Compliance Manager – Clinical Trials

🔥 10 minutes ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 15%

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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

• Manage all aspects of GxP audits and Regulatory Authority inspections for the company, investigator sites, and clients • Lead and/or review complex internal and external audits and inspections for compliance with quality assurance processes, standards, global regulatory guidelines, and client contractual obligations • Provide consultation to project teams and clients on GxP audit and inspection readiness, preparation, management, and follow-up • Serve as the primary contact for client audit and inspection discussions • Support client audits and GxP regulatory authority inspections, including risk assessment and mitigation, staff training, mock interviews, preparation activities, documentation review, hosting, facilitation, and post-inspection follow-up • Lead, review, and approve client, internal, and GxP audit and regulatory inspection reports • Support root-cause investigations and CAPA development; follow up on implementation, effectiveness checks, and supporting evidence • Contribute to lessons-learned discussions and company-wide improvement initiatives • Develop and share guidance, reference information, repositories, communication channels, policies, procedures, guidance documents, and quality-management-system training • Lead process-improvement initiatives and collaborate cross-functionally to ensure execution, completion, and continuous improvement • Develop compliance-activity tracking tools and materials and analyze trends • Mentor less experienced staff and serve as project lead for group projects • Identify and resolve issues affecting the quality or integrity of clinical research programs • Prepare and present audit findings and related information at departmental, internal operations, and client meetings • Focus primarily on the APAC region 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, including required GCP knowledge • Strong understanding of regional clinical research regulations, requirements, and guidelines, plus applicable global guidelines / requirements • Experience with quality management systems and regulatory frameworks • Experience conducting internal audits and supporting, hosting, and managing client audits and GxP regulatory inspections across the region • Proven experience in root cause analysis • Strong problem-solving, critical-thinking, risk-assessment, and impact-analysis abilities • Exceptional verbal, written, and presentation skills, including medical and scientific terminology • Strong negotiation and conflict-management skills • Ability to mentor and direct staff and work independently or in a team environment • Strong organizational and time-management skills; flexibility and ability to multitask and prioritize complex demands/workload • Advanced proficiency in Microsoft Office Suite and compliance-related software • Veeva QMS experience is a plus • 1+ years of management/leadership experience preferred • Biology, Pharmacy, or related field preferred • Ability to work standard Monday–Friday schedule

🏖️ Benefits

• Global team environment • Career development opportunities • Collaboration and professional development environment • Meaningful work contributing to global health, safety, and scientific progress

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