Clinical Quality Manager

Responsible for overseeing the planning and implementation of the QA program covering research compliance, audits, and QA quality management system. Also responsible for Learning and Development program and its implementation and management.

Responsibilities

1. Ensuring compliance with global and local clinical research regulations and standards.
2. Develop and implement the quality and compliance program including audits, development of functional SOPs.
3. Accountable for the implementation of the role-based training curriculum, its documentation.
4. Conducting quality audits and supporting inspections and external audits. Plan and conduct complex/for cause audits.
5. Stay updated on changes in applicable regulation and prepare the organization for compliance.
6. Developing and maintaining quality assurance policies and procedures to ensure consistent quality standards across all departments and products.
7. Leading and coordinating cross-functional teams to address quality issues and drive corrective actions.
8. Establishing key performance indicators (KPIs) to measure and monitor quality performance and identify areas for improvement.
9. Identifying areas for improvement in quality control processes.
10. Implement Risk Assessment and Mitigation Plan, conducting risk assessments to anticipate potential quality issues and developing, managing mitigation strategies.
11. Providing regular reports and updates to senior management on quality performance, compliance, and improvement initiatives. Escalate critical quality/compliance issues/findings or trends.
12. Developing and maintaining strong relationships with external auditors and regulatory bodies to ensure compliance with industry standards.
13. Leading quality improvement projects and initiatives to enhance overall research quality across the research organization.

Qualifications

1. Bachelor's degree in a life sciences (medicine, dentistry, pharmacy, biological sciences).
2. 7+ years of experience in clinical research quality assurance and auditing.
3. 2+ years of employee management experience.
4. 2+ years of experience in clinical research learning management.
5. Certified Clinical Quality Auditor.
6. Expertise in GXPs associated with Clinical research.
7. Familiarity with regulatory requirements and industry standards related to quality management in UAE.
8. Certification in quality management, such as Six Sigma, Lean, or ISO 9001 desirable.