QA Compliance Manager – Clinical Trials

• 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

• 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

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