Head of GLP

Key Responsibilities

1. Lead and drive the organization’s Good Laboratory Practice (GLP) compliance strategy, ensuring all laboratory operations, testing, and research activities adhere to applicable national and international GLP regulations;

2. Oversee the development, implementation, and continuous improvement of GLP-compliant policies, standard operating procedures (SOPs), and guidelines across the organization;

3. Ensure all laboratory personnel are adequately trained and consistently comply with GLP requirements, regulatory standards, and internal policies;

4. Monitor and ensure sustained GLP compliance across all research, development, and testing activities;

5. Lead internal and external GLP audits; manage audit findings and ensure timely implementation of effective corrective and preventive actions (CAPA);

6. Prepare for and support regulatory inspections by ensuring readiness of documentation, facilities, systems, and records in accordance with GLP requirements;

7. Coordinate and manage responses to regulatory audit and inspection findings, including implementation of required procedural or operational improvements;

8. Lead and manage the GLP compliance team by providing strategic direction, mentorship, and performance oversight;

9. Develop and deliver training programs on GLP compliance, regulatory requirements, data integrity, and quality management systems for laboratory personnel and relevant stakeholders;

10. Promote a culture of quality, compliance, and continuous improvement across the GLP function and the wider organization;

11. Ensure the proper design, conduct, and documentation of preclinical studies, testing protocols, and data management processes in full compliance with GLP standards;

12. Review and approve study protocols, reports, and final documentation to ensure accuracy, completeness, and data integrity;

13. Develop and implement risk management frameworks to identify, assess, and mitigate GLP-related risks across research and testing activities;

14. Proactively address compliance gaps and ensure robust mitigation strategies are in place to prevent regulatory non-compliance;

15. Establish and maintain an effective GLP compliance monitoring system, including periodic reviews to ensure operational risks are minimized;

16. Lead continuous improvement initiatives to enhance GLP compliance, laboratory efficiency, and data integrity;

17. Provide regular reports and updates to senior management on GLP compliance status, audit outcomes, risk areas, and CAPA effectiveness;

18. Monitor evolving regulatory requirements and industry best practices, ensuring timely organizational alignment and compliance;

19. Manage and oversee relationships with external vendors, laboratories, and Contract Research Organizations (CROs) to ensure outsourced activities meet GLP and regulatory standards;

20. Oversee contracts, quality assurance processes, and compliance activities related to third-party vendors and collaborators involved in GLP studies; and

21. Perform any other duties as assigned by Management from time to time.

Qualifications and Experience:

1. Malaysian citizens;

2. Minimum Bachelor’s Degree in Life Sciences/Pharmacy/Pharmaceutical/Sciences/Biochemistry/ Chemistry or any related field and recognized by the Malaysian government from a local or foreign higher education institution or a qualification recognized as equivalent;

3. Preferably with a minimum five (5) years of working experience in the GLP;

4. Strong communication, organizational and problem-solving skills;

5. Ability to work independently in a structured and regulated environment; and

6. Proficient in Microsoft Office (Word, Excel, Powerpoint).