Associate Director, Audit Management - Medical Device (Remote)

Job Description

The Audit Management Associate Director is responsible for the audit and inspection management for assigned activities, inclusive of internal and external processes. This role has responsibility for design and execution of compliance audits across GMP suppliers through the development of a risk-based audit program designed to support activities across Vertex business functions. 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. 

Key Duties and Responsibilities: 

• Provides Medical Device/Combination Product Regulation expertise and leadership. 

• Contributes to the overall direction of the GMP 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 regulatory requirements, and guidance, 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 GMP 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 Global Quality Compliance to