Associate Director, Audit Management

Vertex Inc.•Boston, MA

2d•Remote

About The Position

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 primarily across GCP/GLP suppliers and clinical investigator sites 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 laboratory or clinical practices. Regularly applies specialized domain knowledge to assignments and provides technical recommendations to management. May have people management responsibilities within the organization including financial accountabilities and human resource responsibilities for assigned staff.

Requirements

Advanced/specialized and in-depth knowledge of: GxP quality systems, including GCP/GLP audit processes
Regional/international knowledge of GCP/GLP regulations
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 in GCP/GLP audit and inspection management functions

Responsibilities

Contributes to the overall direction of the GCP/GLP 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
Contributes to 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
Partners with and engages stakeholders and leadership across functional areas and QA in risk evaluation when contributing to the development of the internal audit schedule
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
Executes 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
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