• Quality Manager, East Asia Jobs in Malaysia - 1015632

    George Clinical Asia Pacific Limited
  • 5 - 7 Years
  • Malaysia - Kuala Lumpur - Petaling Jaya
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  • Posted 5 days ago
  • Job Views: 2
  • Job Applicants: Less than 10

Job Description

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 Asia

Providing advice to stakeholders on SOPs, regulatory requirements and GCP standards

Supporting Project Operations Team to proactively assess risk and quality management cross the clinical trials

Verifying the implementation of Quality Management System through co-monitoring visits, process reviews, gap analysis and audits

Making recommendations for continuous process improvement

Identifying, reporting and escalating compliance/quality issues and emerging risks to the Head, Global Quality

Contribute to review local CAPA, collate and analyse of quality metrics

Delivery of regional and global training programme

Providing support to office audits and site inspections by Sponsors

Our ideal candidate will possess

At least 5 years’ 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 preferred

Previous experience in a CRO highly regarded

Tertiary qualifications in a related science or health care discipline

Strong knowledge of ICH-GCP guidelines, global and local ethical and regulatory requirements

Ability to coach and mentor staff in relation to noncompliance and performance issues

Strong written and verbal communication skills including sound presentation skills

Experience in the training of clinical research staff desirable

Demonstrated customer service focus

Excellent problem solving and analytical skills

Ability 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

Profile Summary

Type:Company Job


Industry:BioTechnology/Pharmaceutical/Clinical research

Salary:Not Disclosed

Deadline:11th Mar 2020

Company Profile

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.

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