Senior Professional Quality Management – GCP Experience Required

About the role

Syneos Health is seeking a senior professional to provide quality management support across clinical departments, focusing on Good Clinical Practice (GCP) and related regulatory frameworks. The role involves collaborating with Clinical Monitoring teams, auditors, and operational staff to ensure compliance and drive continuous improvement.

Key responsibilities

• Support Clinical Monitoring teams during sponsor site audits, including preparation and quality checks of training documentation, TMF and study documents.
• Assist during audits and inspections to identify issues, conduct root cause analysis, develop corrective and preventive actions and perform effectiveness checks.
• Provide quality consultancy for Quality Management and Operations, review controlled documents for alignment with company standards, and advise auditors and regulatory inspectors.
• Lead medium‑scale quality management projects, drive process improvements and ensure timelines meet client and company requirements.

Required profile

• Bachelor’s degree in a scientific or health‑care discipline or equivalent experience.
• Experience with Good Clinical Practice (GCP) and familiarity with GLP and GMP concepts.
• Strong attention to detail, organizational and interpersonal skills, and ability to work independently.
• Project and customer management experience with the ability to handle multiple tasks and meet deadlines.

Required skills

• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint).
• Knowledge of Good Clinical Practice (GCP) guidelines.
• Understanding of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) principles.