Clinical Quality Manager

2 weeks ago

Malaysia ICON plc Full time

As a Clinical Quality Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies, and vaccines for many of the world’s most challenging diseases including cancer, cardio-metabolic diseases, Alzheimer’s, and infectious diseases. Be ready to work in a solid partnership and an environment driven by innovation and continuous improvement.

**What you will be doing**:
The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the Clinical Quality Managers support audits, inspections as well as Quality Control and local training activities.
- Local country SME for regulations and processes
- Coordinate and execute local learning and development programs
- Coordinate and oversee quality control activiites
- POC for Quality Assurance and Regulatory Authorities during Audits and Inspections
- Oversee and manage Clinical Supplies inquiries and vendors

**You are**:

- Tertiary degree qualified in relevant life science field
- A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
- Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.
- Experience in managing audits and inspections, and delvering training sessions
- Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.
- Excellent communication and project management skills

**Why ICON?**

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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