Position: Project Technical Lead – GCP Clinical Laboratory
Location: UAE
Experience: 8+ Years
Qualification: PhD / MSc (Life Sciences)
About the Role
We are hiring a Project Technical Lead – GCP Clinical Laboratory for a strategic greenfield GLP/GCP facility in the UAE. This role will act as the technical authority for setting up and operationalizing a world-class clinical laboratory, ensuring compliance with global standards and regulatory requirements.
Key Responsibilities
- Lead end-to-end laboratory setup, including GCP/GLP design, workflows, and infrastructure planning
- Drive ISO 15189 accreditation and establish a robust Quality Management System (QMS)
- Oversee clinical sample management and ensure proper chain-of-custody for Phase I–II trials
- Manage GLP preclinical lab operations in line with OECD GLP standards
- Lead bioanalytical method development & validation (LC-MS/MS preferred) for PK/PD studies
- Establish cold chain systems and ensure compliance with global standards
- Act as the primary technical interface with regulatory authorities (DoH Abu Dhabi, MOHAP)
- Support licensing, audits, and inspections
- Collaborate with cross-functional teams to ensure timely project execution
Key Requirements
- 8+ years of experience in clinical laboratory operations (GCP environment)
- Strong experience with ISO 15189 accreditation
- Proven expertise in GLP/GCP compliance and regulatory frameworks
- Hands-on experience in bioanalytical techniques (LC-MS/MS preferred)
- Exposure to clinical trials (Phase I–II) sample handling
- Experience in greenfield lab setup will be highly preferred
- Strong stakeholder management and leadership skills
Preferred Background
- Candidates from leading CROs / Clinical Research Labs
- Experience working with international regulatory bodies
Compensation
Competitive UAE expat package (best in industry)
Interested candidates can share their profiles at [Confidential Information]
