• Contributes to the overall direction of the Gx P audit program, performance, and effectiveness of the audit program in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with Gx P regulatory requirements, and guidances, etc.
• Partners with QA leadership and business leadership for coordination and alignment in ensuring overall quality of audit and adequacy in remediation/improvement across vendors and internal operations
• Directs the development and maintenance of the integrated and risk-based Gx P Audit Plan and provides leadership in setting the direction to plan development, execution, and adherence
• Partners with and engages stakeholders and leadership across functional areas and QA in risk evaluation when determining the internal audit schedule
• Collaborates with other leaders in Audit and Inspection Management to provide direction and alignment of risk based approaches, ensuring that Gx P audit strategies and processes are established to:
• Enable the execution of Gx P vendor qualification and requalification audits
• Provide oversight, including budget forecast and tracking, for audits that are outsourced
• Execute directed or For-Cause audits, as needed
• Engages in preparation, support and follow-up activities for inspection readiness
• Supports due-diligence and business development activities, as requested
• Serve as quality management system representative
• Participates in collaborative review of impacted SOP/WI
• Reviews and analyzes key performance Indicator data and trends
• Analyzes risk and proposes remedial, corrective and /or preventive actions
• May participate on process improvement initiatives
• Provides cross-functional support across Vertex Quality Assurance team
• May manage 1-3 Gx P Audit and Inspection Management Team Members

• Advanced/specialized and in-depth knowledge of:
• Gx P audit processes
• Gx P quality systems
• Regional/international knowledge of Gx P regulations
• CMC documentation
• Investigation, root cause analysis, and effectiveness check processes, tools, and techniques
• Change management and risk management principles and process knowledge

• Bachelor's degree in relevant field is required
• Typically requires 8 years of experience or the equivalent combination of education and experience
• Experience as Gx P generalist or in applicable specialty area such as manufacturing, distribution, laboratory, or clinical practices

$149,280 - $223,920 Remote-Eligible