Biorasi - Senior GCP Auditor

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’s 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

Audit, GermanyEP Advisory Jobs