About the job
Position Title: Head of Quality Management, Global Contract Research Organisation (CRO).
Department: Quality Management
Reports To: Chief Executive Officer
Role Summary:
Senior leadership role responsible for defining and overseeing the organization’s quality strategy, ensuring compliance with global regulatory standards, and embedding quality principles across clinical research operations.
Key Responsibilities:
- Lead and implement a company-wide Quality Management System (QMS) aligned with GxP, ICH-GCP, and ISO standards.
- Provide strategic quality oversight across all clinical trial and operational processes.
- Ensure regulatory compliance and represent the company in external audits and inspections.
- Direct internal and external audit programs and manage CAPA implementation and effectiveness checks.
- Collaborate cross-functionally to integrate quality into clinical project execution and organizational decision-making.
- Oversee QA/QC teams and drive a culture of continuous improvement and operational excellence.
Requirements:
- Experience:
- Minimum 5 years in quality roles within a CRO or pharmaceutical company, including 2–3 years in clinical monitoring.
- Leadership experience within a CRO is essential.
- Knowledge:
- Deep understanding of ICH-GCP, GxP, ISO standards, and clinical trial regulatory frameworks.
- Skills:
- Strong leadership, decision-making, communication, and organizational abilities.
- Proficient in quality documentation, audit processes, and risk-based thinking.
- Education:
- Degree in life sciences, medical sciences, pharmaceuticals, or a related field