Senior Quality Assurance Lead at Emerald Clinical Trials

Petaling Jaya, Selangor, Singapore -

Full Time

Start Date

Immediate

Expiry Date

18 Jan, 26

Salary

0.0

Posted On

20 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Clinical Research, Regulatory Compliance, GCP Standards, Risk Assessment, Training Development, Audit Management, SOP Management, Project Support, Quality Metrics, CAPA Review, Stakeholder Communication, Global Standards, Continuous Improvement, Team Collaboration, Health-Related Field

Industry

Biotechnology Research

Description

At Emerald Clinical Trials, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing. Our therapeutic expertise spans renal, cardiometabolic, and oncology—areas where we make a significant impact on improving global health. At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster results—bringing therapies to patients in need. 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 Tertiary qualifications in a health-related field, or relevant equivalent work experience At least 7-8 years’ experience in the clinical operations/project management/quality assurance or quality management field including phase II-IV global studies Experience and/or qualifications in the development, delivery, and facilitation of training to clinical research staff desirable 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: • Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology. • Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial. • Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges. What We Offer We understand that great work happens when people feel valued and supported. That’s why we provide: • Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience. • Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role. • Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role. • Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events. • Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients. 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.

Responsibilities

The Senior Quality Assurance Lead ensures quality management processes are compliant with applicable codes and regulations. Responsibilities include auditing, training, and supporting project teams to embed quality into clinical trials.