Regeneron

Associate Director, CSV Auditing

Regeneron

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $157,200 - $256,600 per year

Job Level

Senior

About the role

  • 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!
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Computer System Validation (CSV)auditingrisk-based quality auditingaudit methodsregulatory inspectionsFDA regulationsEU regulationsICH guidance documents
Soft Skills
leadershipguidancesupervisionstrategic partnershipstrainingmentoringcommunication
Certifications
Bachelor's degreeMaster’s degree