Quality Compliance Lead, Sr Manager

Location: Shanghai, China; local travel of approximately 20% is required, with possible overseas travel.

Company

hirify.global is a biotechnology company developing medicines and conducting clinical development programs.

What you will do

• Lead end-to-end quality oversight for clinical trials, associated procedures, and suppliers operating in China.
• Develop and implement risk-based quality strategies and regional Quality Plans across the full clinical trial lifecycle.
• Review protocols, identify critical data and processes, and assess and mitigate risks affecting patient safety, welfare, rights, and data integrity.
• Coordinate audits, inspection readiness, issue management, deviations, CAPAs, serious breaches, and privacy issues.
• Analyze and communicate compliance metrics and trends to stakeholders and senior leadership.
• Implement innovative quality oversight methods using AI, natural language processing, and advanced data analytics.

Requirements

• Bachelor’s degree in an appropriate discipline, such as biomedical science or nursing, or equivalent experience.
• At least 7 years of experience in the pharmaceutical industry and in-depth knowledge of ICH GCP standards.
• At least 4 years of experience in quality management, quality assurance, or a related pharmaceutical or biotechnology function focused on risk-based quality and quality by design.
• Experience with Quality Management Systems and electronic QMS platforms such as Veeva or TrackWise.
• Strong understanding of clinical R&D, global, regional, and China regulations, regulatory submissions, and inspection management.
• Professional ability to communicate technical concepts and literature in English and Mandarin is required.

Culture & Benefits

• Cross-functional collaboration with R&D Quality teams, local and global leadership, clinical teams, and other stakeholders.
• People leadership, mentoring, and partnership responsibilities across China Development.
• Opportunity to develop expertise in the China market and clinical development strategy.
• Local travel is expected at approximately 20%; overseas travel may be required based on business needs.