Manager Of Gcp Auditing

Overview

• Lead clinical quality assurance initiatives, ensuring compliance with Good Clinical Practices (GCP) and regulatory standards across clinical sites and vendors.
• Develop and implement audit strategies to uphold organizational quality and regulatory compliance goals effectively.
• Collaborate with cross-functional teams to address compliance issues and enhance clinical quality processes.
• Provide expertise in vendor qualification, document audits, and regulatory readiness activities.
• Deliver comprehensive training on GCP standards to internal teams and external collaborators.
• Maintain and oversee audit tracking systems, ensuring accurate reporting of metrics and compliance status.
• Support regulatory inspections, ensuring organizational preparedness and adherence to compliance evaluations.
• Drive continuous improvement in clinical quality assurance practices and organizational compliance culture.

Key Responsibilities & Duties

• Conduct and oversee GCP audits for clinical sites, vendors, and documentation, ensuring adherence to regulatory standards.
• Collaborate on deviation management, including root cause analysis and corrective action plan development.
• Plan and execute audits for GLP and GCP vendors, maintaining compliance with industry regulations.
• Review audit findings and ensure effective implementation of corrective actions meeting regulatory requirements.
• Provide training and guidance on GCP standards to clinical investigators and organizational teams.
• Collaborate with clinical development teams to address audit findings and improve operational practices.
• Maintain audit tracking systems and provide regular metrics reports to management.
• Assist in regulatory inspections, preparing documentation and ensuring compliance readiness.

Job Requirements

• Bachelor’s degree in Nursing, Health Science, or a related field is required.
• Minimum of 8 years of experience in clinical auditing and compliance within the healthcare or pharmaceutical industry.
• Proficiency in GCP auditing, including investigational sites, vendor audits, and clinical documentation.
• Comprehensive knowledge of US and ICH GCP regulations and guidelines.
• Experience with clinical safety and trial management systems such as ARISg and TrackWise.
• Strong interpersonal, oral, and written communication skills for effective collaboration.
• Ability to manage multiple priorities, meet deadlines, and work independently or in teams.
• Willingness to travel 40-60% for audits, inspections, and compliance evaluations.