Sr. Quality Assurance & Regulatory Compliance Analyst

Location: Shanghai, China

Company

hirify.global is part of Thermo Fisher Scientific and provides clinical research services and healthcare technology supporting the delivery of clinical trials and evidence for life-changing therapies.

What you will do

• Lead quality assurance and regulatory compliance activities across clinical research operations.
• Review and approve CAPAs, deviations, notes to file, compliance reports, and other quality documentation.
• Plan, conduct, document, and report internal audits, while supporting vendor, sponsor, supplier, and regulatory audits.
• Monitor quality metrics, investigate trends and risks, and verify the effectiveness of corrective actions.
• Maintain quality systems, SOPs, work instructions, training materials, and compliance processes.
• Provide training, coaching, and mentorship while escalating quality concerns and recommending mitigation actions.

Requirements

• Bachelor’s degree in life sciences, biological sciences, healthcare, regulatory affairs, quality assurance, or a related scientific field.
• At least 5 years of experience in quality assurance, regulatory compliance, auditing, inspection readiness, or related functions within a regulated environment.
• Strong knowledge of Good Clinical Practice, quality management systems, regulatory requirements, and industry quality standards.
• Experience with internal, external, vendor, supplier, sponsor, or regulatory audits, as well as CAPA and deviation management.
• Understanding of clinical research processes, clinical trial operations, quality risk assessment, and compliance investigations.
• Strong analytical, communication, organizational, and stakeholder-management skills, with proficiency in Microsoft Office.

Nice to have

• Quality Auditor certification or equivalent quality certification.

Culture & Benefits

• Competitive compensation, benefits, and incentives.
• Employee events and hybrid work technology support.
• Work within a global and inclusive organization focused on continuous improvement and clinical research impact.