An opportunity has arisen for an experienced and committed Quality Manager within our growing team in East Asia This role willbe working closely with our Global Quality Team to implement and support quality strategy across George Clinical East Asia teams in Hong Kong Malaysia Taiwan South Korea Singapore Philippines Thailand etc The key responsibilities include Implementing and support Quality Management System in East AsiaProviding advice to stakeholders on SOPs regulatory requirements and GCP standardsSupporting Project Operations Team to proactively assess risk and quality management cross the clinical trialsVerifying the implementation of Quality Management System through co-monitoring visits process reviews gap analysis and auditsMaking recommendations for continuous process improvementIdentifying reporting and escalating compliance quality issues and emerging risks to the Head Global QualityContribute to review local CAPA collate and analyse of quality metricsDelivery of regional and global training programmeProviding support to office audits and site inspections by Sponsors Our ideal candidate will possess At least 5 years and rsquo experience in clinical operations project management quality assurance or quality management field in phase II-IV global studies experience in conducting clinical research compliance activities or audits preferredPrevious experience in a CRO highly regardedTertiary qualifications in a related science or health care disciplineStrong knowledge of ICH-GCP guidelines global and local ethical and regulatory requirementsAbility to coach and mentor staff in relation to noncompliance and performance issuesStrong written and verbal communication skills including sound presentation skillsExperience in the training of clinical research staff desirableDemonstrated customer service focusExcellent problem solving and analytical skillsAbility and willingness to travel Candidates must have an excellent track record in working with the East Asia region in order to be considered for this role This is an excellent opportunity to work with a growing and global CRO that manages a range of global projects We offer a competitive salary package flexible working conditions and strong growth and development opportunities Please follow us on LinkedIn to learn more your future with George Clinical We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted
Type : Company job
Role : Manager
Industry : BioTechnology/Pharmaceutical/Clinical research
Salary : Not Disclosed
George Clinical is the clinical trials management arm of The George Institute for Global Health and provides contract research services to pharmaceutical companies as well as supporting internal Institute projects. The George Institute has an international reputation in designing and implementing clinical research in a large range of therapeutic areas.
George Clinical leverages this expertise in scientific leadership, and the associated investigator networks when conducting clinical research for their sponsors.
George Clinical has staff and facilities in Australia, East Asia, India, China, the United States, the United Kingdomand has established partnerships with other leading research organisations in North America, Europe and Asia for a truly global reach. Please visit our Careers page for more information on our oganisation and to view other opportunities globally.