Principal Auditor - Client Relationship Quality Assurance (crqa)

ICON

Georgia, USA
Not specified; competitive within each country; ra...
Hybrid
7 years qa experience in pharma or cro
3 years leadership role experience
In-depth knowledge of ich-gcp and fda regulations
ICON is seeking a Principal Auditor for Quality Assurance within their Client Relationship Quality Assurance (CRQA) team, located in various countries including the USA, Poland, Bulgaria, South Africa, and the UK. The role focuses on ensuring compliance and quality in clinical trials while fostering strong relationships with sponsor companies

Job Summary

  • The Principal Auditor will play a pivotal role in ensuring the quality and compliance of clinical trials while building successful relationships with sponsor companies.
  • Responsibilities include managing quality risk mitigation, conducting root cause analysis, and interpreting regulatory requirements such as ICH-GCP and FDA regulations.
  • ICON offers a competitive salary, diverse benefits including health insurance and retirement planning, and a culture dedicated to inclusion and belonging.

Matching Summary

Match Score: 85

ICON is seeking a Principal Auditor for Quality Assurance within their Client Relationship Quality Assurance (CRQA) team, located in various countries including the USA, Poland, Bulgaria, South Africa, and the UK. The role focuses on ensuring compliance and quality in clinical trials while fostering strong relationships with sponsor companies.

Salary

Not specified; Competitive within each country; Range of additional benefits included

Skills & Requirements

Must-have

  • 7 years QA experience in pharma or CRO
  • 3 years leadership role experience
  • In-depth knowledge of ICH-GCP and FDA regulations
  • Experience with Audit Compliance Management System
  • Root cause analysis and quality issue escalation

Nice-to-have

  • Advanced degree in Life Sciences or Pharmacy
  • Strong stakeholder communication skills
  • Consultancy support for GxP guidance
  • Data trending and interpretation capabilities

Key Requirements

  • Bachelor's degree in Life Sciences, Pharmacy, or related field
  • Minimum 7 years of experience in quality assurance
  • At least 3 years in a leadership role
  • Knowledge of clinical trial regulatory guidelines

Work Rights

Not specified

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