Inspections Compliance Analyst (GxP)

TL;DR

Inspections Compliance Analyst (GxP): Coordinating and managing regulatory inspection and audit activities to ensure corporate compliance with GxP standards and industry expectations. Focus on managing CAPA processes, hosting regulatory inspections, and investigating potential GCP breaches within the Quality Management System.

Location: Must be based in Shanghai, China. This is a remote-based position that may require infrequent visits to company offices.

Company

hirify.global is a global research technology company, part of Thermo Fisher Scientific, focused on delivering clinical trial data and insights.

What you will do

• Coordinate and manage regulatory inspection and audit activities across all regions.
• Promote continuous improvement by managing root cause analysis and CAPA implementation.
• Host and manage regulatory inspections for the company and its clients.
• Analyze inspection observations and generate effective regulatory responses.
• Maintain the Regulatory Inspection Library and associated QM system documentation.
• Collaborate with departments to investigate and manage potential serious breaches of GCP.

Requirements

• Must be based in or near Shanghai, China.
• Experience in regulatory inspection coordination and audit management.
• Strong understanding of GxP, GCP, and ISO quality standards.
• Proven ability to manage CAPA processes and root cause analysis.
• Excellent documentation and communication skills for regulatory inquiries.

Culture & Benefits

• Part of a large, established global organization (Thermo Fisher Scientific).
• Opportunity to work on high-impact clinical trial compliance.
• Collaborative environment working across multiple departments.
• Flexible remote-based work arrangement with occasional office presence.