Clinical Quality Compliance Specialist

ICON; Kuala Lumpur; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading clinical research organization in Kuala Lumpur seeks a Clinical Quality Compliance Specialist to assist in maintaining quality standards across clinical trials. Candidates should have a relevant scientific degree and experience in clinical quality assurance. This role offers competitive salary and a comprehensive benefits package focused on well-being and work-life balance.

Benefits

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualifications

• Previous experience in clinical quality assurance or compliance within the pharmaceutical, biotech, or CRO industry.
• Knowledge of FDA/EMA regulations, ICH-GCP guidelines, and ISO standards.

Responsibilities

• Assist in the development and implementation of quality management systems.
• Participate in audits and inspections, supporting preparation and documentation.
• Conduct quality reviews of clinical trial documentation.

Skills

Attention to detail

Analytical skills

Communication skills

Organizational skills

Problem-solving skills

Education

Bachelor's degree or higher in a relevant scientific discipline

Job description

Clinical Quality Compliance Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Clinical Quality Compliance Specialist to join our diverse and dynamic team. As a Clinical Quality Compliance Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

What you will be doing

• Assisting in the development and implementation of quality management systems and processes to ensure compliance with regulatory requirements, industry standards, and company policies.
• Participating in internal and external audits and inspections, supporting preparation, documentation, and response activities.
• Conducting quality reviews of clinical trial documentation, protocols, and study reports to identify areas for improvement and ensure adherence to quality standards.
• Collaborating with cross-functional teams to address quality issues, implement corrective and preventive actions, and drive continuous improvement initiatives.
• Providing support and guidance to colleagues on quality compliance matters, promoting awareness and understanding of quality standards and best practices.

Your profile

• Bachelor's degree or higher in a relevant scientific discipline or healthcare-related field.
• Previous experience in clinical quality assurance or compliance within the pharmaceutical, biotech, or CRO industry.
• Knowledge of regulatory requirements, including FDA/EMA regulations, ICH-GCP guidelines, and ISO standards.
• Strong attention to detail and analytical skills, with the ability to review and interpret complex documentation and data.
• Excellent communication, organizational, and problem-solving skills, with the ability to work effectively in a team environment.

What ICON can offer you

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

Inclusion & Belonging

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply.