Added
5 days ago
Type
Full time
Salary
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soc iso audits life sciences gxp

πŸ“‹ Description

  • Hosts customer audits and supports regulatory audits
  • Documents audit findings and authors audit response
  • Conducts internal audits in support of the annual audit plan
  • Manages informational requests for internal and external stakeholders
  • Performs compliance outreach presentations
  • Supports and coordinates with internal departments related to third-party audits (SOC, ISO)

🎯 Requirements

  • BS/BA in Science, Engineering, Information Management, or related field
  • 3+ years experience in a regulated quality/compliance role
  • Good understanding of life sciences regulations (GxP, GMP, GCP, ICH, ISO)
  • Experience hosting audits or regulatory inspections as SME
  • Excellent customer service and collaboration
  • Proficiency with MS Excel and PowerPoint

🎁 Benefits

  • Foundation in quality principles and standards (ISO/IEC/IEEE/ITIL/ICH)
  • 2+ years in an audit-specific life sciences role
  • Veeva products experience
  • Understanding of computer system validation
  • Knowledge of information security and risk management
  • Experience with audits/inspections in regulated environments
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