Manager Of Gcp Auditing

Overview

• Manage clinical quality assurance (CQA) processes, ensuring compliance with Good Clinical Practices (GCP) and regulatory standards.
• Conduct audits for clinical sites, vendors, and internal systems to maintain quality standards.
• Collaborate with cross-functional teams to resolve compliance issues and implement corrective actions.
• Support clinical development activities through vendor qualification and document audits.
• Provide training and guidance on GCP standards to internal teams and external collaborators.
• Develop and oversee audit plans, ensuring alignment with organizational goals and regulatory requirements.
• Maintain audit tracking systems and report metrics to management.
• Assist in regulatory inspections and ensure readiness for compliance evaluations.

Key Responsibilities & Duties

• Conduct and supervise GCP audits for clinical vendors, sites, and documents.
• Collaborate on deviation management activities, including root cause analysis and CAPA development.
• Plan and execute GLP and GCP vendor audits, ensuring compliance with standards.
• Review audit reports and ensure corrective actions meet regulatory requirements.
• Provide GCP training for clinical investigator meetings and internal teams.
• Collaborate with clinical development teams to resolve audit findings and improve practices.
• Maintain tracking systems for audit activities and provide periodic metrics reports.
• Assist in regulatory inspections and prepare documentation for compliance evaluations.

Job Requirements

• Bachelor’s degree in Nursing, Health Science, or a related field.
• Minimum of 8 years of experience in clinical auditing and compliance.
• Proficiency in GCP auditing, including clinical reports, investigational sites, and vendor audits.
• Knowledge of US and ICH GCP regulations and guidelines.
• Experience with clinical safety and trial management systems like ARISg and TrackWise.
• Strong interpersonal, oral, and written communication skills.
• Ability to prioritize tasks, manage competing timelines, and work independently or collaboratively.
• Willingness to travel 40-60% for audits and inspections.