Clinical Compliance Manager role focused on conducting internal and external audits, managing quality assurance activities, and ensuring adherence to regulatory standards across clinical development programs. The position involves audit reporting, root cause analysis, compliance tracking, and mentoring staff within a matrix organization.
Responsibilities
- Conduct complex internal and external audits against quality standards and regulatory guidelines
- Identify quality issues, determine root causes, and develop corrective action strategies
- Deliver audit reports to management and plan quality services for contracted audits
- Lead process and quality improvement initiatives and develop compliance tracking tools




- Mentor junior staff and serve as project lead for cross-functional group projects

Requirements
- Bachelor's degree in life sciences, nursing, pharmacy, or related field
- 5+ years clinical research experience with minimum 2 years in Clinical Quality or GCP Compliance
- Strong knowledge of ICH E6(R2/R3), EMA/MHRA/FDA regulatory expectations
- Demonstrated experience with CAPA, root cause analysis, and deviation management
- Excellent oral and written communication skills for complex compliance topics
- Experience with clinical quality systems such as Veeva Vault or TrackWise preferred

📌 Compliance Manager (España)
🏢 Thermo Fisher Scientific
📍 España