GCP Senior Auditor

Job Description

Job Description

Join a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies . As a GCP Senior Auditor , you will play a key role in ensuring GXP compliance with global regulatory authorities, driving company-wide compliance initiatives, and strengthening quality management systems to minimize risk in a regulated environment.

This role is ideal for a detail-oriented professional with strong Good Clinical Practice (GCP) experience and a passion for maintaining high-quality standards across global clinical operations.

Key Responsibilities

Audit Leadership & Compliance Oversight

• Plan, conduct, and manage global clinical process and vendor audits across multiple trials.
• Execute internal and external GXP audits, ensuring adherence to FDA, EMA, and ICH GCP guidelines.
• Collaborate with clinical sourcing, supplier quality, and clinical partnerships to evaluate and manage CROs, CMOs, investigator sites, and other vendors.
• Audit clinical systems (IRT, EDC, etc.) with relevant subject matter experts.

Quality Management & Risk Mitigation

Required Qualifications

Preferred Qualifications

Additional Details