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Associate Director, CSV Auditing

DirectorDirectorFull TimeRemoteSeniorTeam 10,001+Since 1988H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

66 days ago

Salary

$157.2K - $256.6K / year

Seniority

Senior

Bachelor Degree11 yrs expEnglish

Job Description

Associate Director, CSV Auditing

Regeneron

• 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

Job 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!

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