Manager Of Gcp Auditing

Job DetailExperience Level ManagerDegree Type Bachelor of Science (BS)Employment Full TimeWorking Type HybridJob Reference 0000018345Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful clinical quality assurance initiatives ensuring regulatory compliance excellence. Collaborate across teams to enhance processes and resolve compliance challenges. Drive audits and gain valuable expertise in GCP standards.Job DescriptionManager of GCP Auditing OverviewLead clinical quality assurance initiatives, ensuring compliance with Good Clinical Practices (GCP) and regulatory standards.Develop and implement audit strategies to uphold 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.Manager of GCP Auditing Key Responsibilities & DutiesConduct 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.Manager of GCP Auditing Job RequirementsBachelor’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.