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
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