JOB DESCRIPTION

The Global Quality Compliance Associate Director is responsible for the audit and inspection management process oversight inclusive of internal and external processes. This role has responsibility for design and execution of audit and inspection program development and system monitoring across GxPs. This role ensures adherence to applicable regulations, industry standards, and to Vertex policies, procedures, and quality standards as set forth in the Quality Management System. This role may be a generalist but more often specializes in manufacturing, distribution, laboratory, or clinical practices. Regularly applies specialized domain knowledge to assignments and provides technical recommendations to management.

KNOWLEDGE AND SKILLS:

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

EDUCATION AND EXPERIENCE:

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

  LI-AR1 #LI-Remote

• Contributes to the overall direction of the GxP 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 GxP 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
• Consults on the development and maintenance of the integrated and risk-based GxP Audit Plan and provides leadership in setting the direction to plan development, execution, and adherence
• Collaborates with other leaders in Audit and Inspection Management to provide direction and alignment of risk based approaches, ensuring that GxP audit strategies and processes are established to:
• Enable the execution of GxP 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 GxP Audit and Inspection Management Team Members