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上海市, 中国
Hybrid
Join Clario, a part of Thermo Fisher Scientific and help drive quality, compliance, and continuous improvement across global clinical research operations. As a Senior Quality Assurance & Regulatory Compliance Analyst, you will play a critical role in maintaining and enhancing quality systems, supporting regulatory compliance initiatives, leading audits, and partnering with operational teams to ensure adherence to regulatory requirements and company standards. This position offers the opportunity to influence quality strategy, mentor colleagues, and contribute to processes that support the successful delivery of clinical trial services worldwide.
What We Offer
Competitive compensation, benefits and incentives
Engaging employee events and hybrid work technology support
The opportunity to be part of a global inclusive team
What You'll Be Doing
Lead and support quality assurance and regulatory compliance activities to ensure adherence to applicable regulations, industry standards, and company procedures.
Review, approve, and analyze corrective and preventive actions (CAPAs), deviations, notes to file (NTFs), compliance reports, and other quality-related documentation.
Monitor, trend, and report quality and compliance metrics, ensuring issues are appropriately tracked, investigated, and resolved in a timely manner.
Plan, conduct, document, and report internal quality audits in accordance with established audit programs and quality requirements.
Perform and support external audits, including vendor, supplier, sponsor, and regulatory inspection activities.
Develop audit reports, communicate findings, and ensure corrective actions are implemented, monitored, and verified for effectiveness.
Review operational data and reports to identify quality trends, risks, and opportunities for continuous improvement.
Perform quality reviews of source documentation, study records, shipments, and quality-related deliverables as required.
Partner with operational leadership to identify, implement, and maintain enhancements to quality systems and compliance processes.
Support the development, review, and maintenance of Standard Operating Procedures (SOPs), work instructions, training materials, and quality guidance documents.
Provide training, coaching, and mentorship on audit processes, compliance reporting, quality systems, and regulatory requirements.
Escalate quality concerns and compliance risks appropriately and provide recommendations for mitigation and resolution.
Support sponsor audits, regulatory inspections, and quality readiness initiatives across the organization.
Stay informed of evolving regulatory requirements, industry best practices, and quality standards applicable to clinical research and healthcare technology environments.
What We Look For
Bachelor's degree in Life Sciences, Biological Sciences, Healthcare, Regulatory Affairs, Quality Assurance, or a related scientific field.
Quality Auditor certification or equivalent quality certification preferred.
Minimum 5 years of experience in Quality Assurance, Regulatory Compliance, Auditing, Inspection Readiness, or related quality functions within a regulated environment.
Strong knowledge of Good Clinical Practice (GCP), quality management systems, regulatory requirements, and industry quality standards.
Experience conducting internal, external, vendor, supplier, sponsor, or regulatory audits.
Demonstrated expertise in CAPA management, deviation management, compliance investigations, and quality risk assessment.
Strong understanding of clinical research processes, clinical trial operations, and applicable regulatory frameworks.
Experience developing and maintaining SOPs, training programs, and quality documentation.
Strong analytical skills with the ability to identify trends, assess risk, and recommend process improvements.
Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
Excellent written and verbal communication skills with the ability to interact effectively with internal and external stakeholders.
Strong organizational skills with exceptional attention to detail and commitment to quality.
Ability to work independently, manage multiple priorities, and adapt effectively in a dynamic and regulated environment.
Demonstrated ability to mentor colleagues, influence stakeholders, and contribute to a culture of continuous improvement.
At Clario, a part of Thermo Fisher Scientific, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.
