Step into the heart of the action as our new Head of Quality GI Kathrinenhof Research Center located near to Rosenheim (Bavaria). This isn't just a job - it's a chance to reshape the landscape of our Quality Management Systems and ensure we're not just meeting, but exceeding local GxP regulations and Boehringer Ingelheim requirements. In this role, you'll be at the forefront of our Animal Health Clinical site operations, driving change, and making a tangible impact on our relentless pursuit of excellence.
If you're ready to ignite your career and make waves in the industry, your journey starts here.
- 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.
- 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
If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com
Recruitment process:
Step 1: Online application - application deadline is August 18th, 2024.
Step 2: Virtual meeting end of August
Step 3: On-site interviews mid of September