Partner with Safety Assessment & Research Operations to understand development programs and related risk factors to drive audit planning & scheduling. Attend project-team meetings and provide quality input as needed
Develop risk-based audit strategy to support pre-clinical programs
Plan and conduct internal, external, routine and for-cause GLP audits worldwide, including audits in preparation for regulatory inspections. Ensure timely responses to audit findings and implement corrective actions as necessary
Guide functional teams through the deviation/CAPA process to ensure robust investigation, timely action, and meaningful improvements to process
Perform Quality Control of documents and data as requested by project teams
Using quality management system tools, analyze audit findings and deviation trends to drive continuous improvement
Provide guidance to employees, external contractors, and development partners on tropics related to GLP compliance and to facilitate identification and resolution of GLP-related issues and concerns
Manage external contractors conducting audits on behalf of Cerevel. This may include providing information about company processes, known quality issues, audit scoping expectations, and/or guidance on use of the audit system
Train staff on regulatory requirements, quality management processes and procedures, and inspection readiness
Play a key role in the coordination of GLP regulatory inspections and compliance audits related to GLP activities
Conduct risk assessments to identify potential areas of non-compliance and implement risk mitigation strategies
Collaborate with teams to establish and maintain a culture of continuous improvement in quality assurance
Stay current with updates to GLP regulations and communicate changes to stakeholders
Collaborate with cross-functional teams to establish and enhance quality systems that support GLP compliance
Represent Cerevel in external industry groups, forums, conferences, and/or professional associations
Lead and/or participate in projects and/or departmental initiatives or other duties as assigned