Key Responsibilities

• 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
• Liaise with 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
• Prepare for and participate in 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

Required Qualifications

• Proven experience in quality assurance role within the pharmaceutical or biotechnology industry
• 5 + years of Quality experience required, including direct GLP audit experience across various audit types
• Knowledge of GLP regulations, guidelines, and industry best practices
• Strong analytical and problem-solving skills
• Detail-oriented with a high-level of accuracy and integrity
• Strong project management, interpersonal, and communication skills
• Skilled user of Microsoft Office applications such as with Word, Excel, PowerPoint, and Outlook
• Ability to travel as needed to support quality and inspection activities

Desired Qualifications

• Experience with the principles of risk analysis and issue management (corrective and preventive action processes).  Experience performing risk assessments and successfully implementing quality plans
• Excellent judgment and interpersonal skills, consensus and relationship building
• Excellent communication and presentation skills
• A high degree of autonomy; takes accountability for work
• Very organized and efficient; delivers high-quality work

Education

• B.S/B.A degree in science, nursing, or related field