Head of GLP/GCP QA

Work at the forefront of pharmaceutical innovation! Bring in your experience and knowledge in our non-clinical health and safety studies by assuming Quality Assurance (QA) responsibility.
Lead, manage, and develop the Quality Assurance team within the Quality NCE department as part of Global Quality Development. Your expertise as the Head of Good Laboratory Practice / Good Clinical Practice is our key to success!

Tasks & Responsibilities

• Design and continuously improve the Quality Management System for non-clinical good laboratory practice (GLP) and good clinical practice (GCP) activities within the GLP Test Facility Biberach, based on the applicable regulatory and internal company requirements.
• Ensure compliance with GLP, GCP and World Health Organization regulations as well as local regulatory requirements related to the performance of non-clinical studies in GLP and clinical study activities in GCP.
• Give strategic direction and drive standardization, as well as the harmonization of global processes with other Boehringer Business units.
• Plan, organize, and direct regulatory activities, including interaction with the local supervisory authority and hosting respective inspections.
• Participate in the performance of audits – internally and at third parties in cooperation with the functional Audit unit within Quality Development and other Boehringer Quality units. Plan audits and evaluate audit results.
• Represent Quality Assurance GLP / GCP in external, international, and inter-company committees.

Requirements

• Master's degree in biology, veterinary, pharmacology, pharmaceutics or related field with several years of professional experience in GLP / GCP regulated environment, especially in the field of quality assurance.
• Excellent knowledge of current GLP / GCP guidelines – national and international.
• Several years of experience leading line or matrix teams with strong leadership skills and ability to provide direction in unusual situations.
• Auditing skills and experience – in the direction of externals and internally with authority inspections.
• Ability to drive and support change, solution orientation, sense of responsibility and entrepreneurial thinking.
• Excellent communication skills coupled with intercultural skills and sensitivity.
• Fluency in German and English, spoken and written.

Ready to contact us?

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 January 13th, 2025.
Step 2: Virtual meeting mid-January.
Step 3: On-site interviews February 10th & 11th, 2025.
Please include the following documents when applying for this position: CV, Cover Letter and other relevant documents.

Please submit your application documents in English.