Senior Quality Assurance Lead • Malaysia, Singapore •

About the Role

The Senior Quality Assurance Lead is responsible for ensuring quality management processes and activities undertaken by George Clinical are conducted in compliance with applicable codes, regulations and principles through the initiatives identified in the Clinical Research Quality Management System (CRQMS). The Senior Quality Assurance Lead is responsible for verifying all clinical research activities are conducted in compliance with the above requirements through audit, training, project support, and quality management activities. The incumbent may be assigned additional responsibilities globally or in other countries. This position will work closely with other Quality team members, project operations, data science and medical, regulatory and safety services staff to support quality across all company activities for the designated countries.

Your Responsibilities

• Provide ongoing advice and support to company personnel regarding application and interpretation of SOPs, regulatory requirements and GCP standards
• Monitor and provide input into the CRQMS to reflect regional needs, recommending initiatives for continuous improvement as needed.
• Support project teams to proactively assess risk and embed quality into trials and address any quality issues, in accordance with the CRQMS
• Identify, report, and escalate compliance and quality issues, and emerging risks, to Global Head, Quality and Line Manager as a priority and, where applicable, to the relevant Project Lead
• Review local CAPA and provide feedback and guidance as needed
• Support and contribute to global SOP / WI management, also working with country representatives and relevant functional area authors to reflect local conditions and regulatory requirements as needed.
• Assist with maintenance of company policies / SOPs / WIs as requested by Director, Quality Processes
• Provide support to functional areas / project teams for hosting third party site audits, sponsor audits and inspections
• Assist with collation of quality metrics
• Deliver Quality induction to new staff, as needed
• Participate in regional / local and functional area meetings as required, sharing, and discussing Quality related topics
• Stay abreast of local and global GCP and relevant regulatory trends and advise relevant stakeholders accordingly
• Provide regular reports to Quality management on the progress of all quality activities for the designated country(ies)

About You

Why Join Us?

At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.

Here’s what makes us stand out :

What We Offer

We understand that great work happens when people feel valued and supported. That’s why we provide :

Interested?

Apply now and help us achieve our mission to improve the health of millions worldwide.

We are an equal‑opportunity employer and encourage applications from all qualified candidates.

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