Associate Director, Audit Management

Vertex Inc. • Boston, MA

7d • 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

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director