Head of Quality GI KRC in Rohrdorf bei BI Vetmedica GmbH

The Position

Tasks & Responsibilities

• In your new role, you will ensure quality for GI projects and manage facility related audits and inspections of study activities.
• Furthermore, you will drive the Quality of the site, manage Quality projects, be a pragmatic partner during product development, manage local suppliers and liaise with agencies.
• You will manage GLP regulatory inspections and corporate audits, including management of the most appropriate action plan to address the findings observed by the regulators/auditors to maintain the GLP certificate of the site.
• In addition, you will implement, maintain, and enhance quality procedures and systems to ensure compliance with internal and external GxP requirements (focus on GLP and veterinary GCP).
• You will create and report quality metrics to quality management.

Requirements

• Master’s degree, Diploma and/or Doctoral Degree (e.g. PhD, MD) with major focus on Quality Management, Clinical Research, Biology, Chemistry, Pharmaceutics or Veterinary and long term experience in quality roles
• Excellent understanding of the requirements and performance of animal trials under laboratory and field conditions as well as sound understanding of the various technologies/ processes involved in manufacturing and testing of drug products including clinical trial supplies
• Strong experience with regulatory inspections and regulations as well as GxP requirements as applied to the site (focus on GLP/GCP)
• Strong leadership skills with the ability to get the buy-in of multiple stakeholders.
Fluency in German and English

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