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Senior, GCP Auditor - CRO

Dusseldorf, Germany
Responsibilities:
  • Direct report to the Head of Global Quality Assurance to ensure Biorasi quality systems, processes, and procedures are compliant with applicable regulations and ICH guidelines.
  • Assist in identifying needs and the planning of internal, investigator, and vendor Quality Assurance audits.
  • Conduct internal, investigator, and vendor Quality Assurance audits when directed.
  • Host and facilitate client initiated audits and regulatory inspections.
  • Effectively communicate audit findings, and Identify and assist in implementing corrective actions and preventive actions (CAPAs).
  • Identify gaps, risks, and areas of continuous improvement within Biorasi‚Äôs quality systems, processes, and procedures.
  • Communicate expectations and direction from Head of Quality to other Biorasi departments and locations to reduce compliance risks and improve global quality and consistency.
 
Qualifications:
  • Bachelor Degree.
  • At least 6 years in drug development and clinical research within the pharmaceutical industry or CRO with at least two years in compliance or clinical safety related area of responsibility.
  • Based in Germany, and willingness to travel internationally between 50% to 75%.
  • Experienced with auditing clinical vendors and investigator sites.
  • Practical knowledge of regulations and ICH guidelines with a focus on clinical and quality and compliance.
  • Auditing certification highly preferred.
  • Must be fluent in German and English; familiarity with Russian would be a plus.
  • Resume written in English is highly preferred 
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