Senior Quality Assurance & Regulatory Compliance Analyst

Location: Shanghai, China

Company

hirify.global is part of Thermo Fisher Scientific and provides clinical trial services and healthcare technology supporting the delivery of 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, supplier, sponsor, and regulatory audits.
• Monitor quality metrics, identify trends and risks, and recommend corrective and preventive improvements.
• Review source documentation, study records, shipments, and quality-related deliverables.
• Maintain quality systems, SOPs, work instructions, training materials, and regulatory guidance while coaching colleagues and escalating compliance risks.

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 in a regulated environment.
• Strong knowledge of Good Clinical Practice, quality management systems, regulatory requirements, and industry quality standards.
• Experience conducting audits and managing CAPAs, deviations, compliance investigations, and quality risk assessments.
• Experience with clinical research processes, clinical trial operations, SOPs, training programs, and quality documentation.
• Strong analytical, organizational, communication, stakeholder management, and mentoring skills; proficiency with Microsoft Office.

Nice to have

• Quality Auditor certification or equivalent quality certification.

Culture & Benefits

• Competitive compensation, benefits, and incentives.
• Employee events and support for hybrid work technology.
• Opportunity to work with a global and inclusive organization.
• Work focused on improving clinical evidence and accelerating access to life-changing therapies.