Associate Director, CSV Auditing

Role Overview

• Provide supervision, guidance and leadership for the Computer System Validation (CSV) Audit Programs
• Create strategic partnerships, directing risk-based quality auditing activities
• Lead/support the development and execution of departmental goals and objectives
• Develop standards and audit methods
• Scheduling, preparing, conducting, reporting and follow-up on routine and directed audits
• Manage GDQA resources for annual audit schedules
• Provide leadership, guidance, and supervision to staff
• Assist with the assessment and prioritization of audit needs
• Represent GDQA on high priority compliance projects
• Provide training and mentoring to GDQA personnel
• Participate in drafting and issuing periodic metrics reports
• May assist in regulatory inspections as a subject matter expert

Requirements

• Bachelor's degree (Master’s degree preferred)
• 11+ years of relevant experience
• 9 years auditing with CSV
• 3 years management experience
• Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs
• Expert knowledge of the FDA and EU regulations and ICH guidance documents

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave) for eligible employees at all levels!