Job Title: Head of Good Laboratory Practice (GLP) / Good Clinical Practice (GCP)
Job ID: 17622
Location: Biberach, Germany
About Boehringer Ingelheim
Boehringer Ingelheim develops breakthrough therapies that improve the lives of humans and animals. Founded in 1885 and still family-owned, we employ over 52,000 people globally, nurturing a diverse, collaborative, and inclusive culture. We are committed to innovation and providing opportunities for growth, both for our employees and the patients and animals we serve.
Job Opportunity
Join us at the forefront of pharmaceutical innovation! As the Head of GLP/GCP within Global Quality Development, you will play a key role in leading the Quality Assurance (QA) team responsible for non-clinical health and safety studies. Your expertise will guide the direction of Quality Management Systems for GLP and GCP activities, ensuring compliance with regulatory requirements and fostering continuous improvement.
Key Responsibilities
Design and Improve Quality Management Systems: Develop and continuously improve systems for non-clinical GLP and GCP activities within the GLP Test Facility, ensuring compliance with regulatory requirements.
Ensure Regulatory Compliance: Maintain compliance with GLP, GCP, and WHO regulations, as well as local requirements for non-clinical and clinical studies.
Strategic Direction & Standardization: Provide strategic direction for QA activities, drive the standardization of global processes, and ensure harmonization across Boehringer Ingelheim.
Regulatory Activities & Inspections: Manage and direct regulatory activities, including interactions with local supervisory authorities and hosting inspections.
Lead Audits: Lead internal and external audits, including at third-party sites, and collaborate with functional audit units within Boehringer Ingelheim.
Representation: Represent QA GLP/GCP in external, international, and inter-company committees, ensuring adherence to global standards.
Requirements
Education: Master’s degree in Biology, Veterinary, Pharmacology, Pharmaceutics, or a related field.
Experience: Several years of experience in GLP/GCP regulated environments, particularly in quality assurance.
Leadership Skills: Proven experience leading teams, with the ability to provide direction in complex situations.
Auditing Experience: Strong experience in auditing, both internally and externally, including regulatory authority inspections.
Communication Skills: Excellent communication skills, with sensitivity to intercultural differences.
Language Skills: Fluency in German and English (spoken and written).
Application Process
Step 1: Online application (deadline: January 7th, 2025)
Step 2: Virtual meeting in mid-January
Step 3: On-site interviews (February 10th & 11th, 2025)
Please submit your CV, cover letter, and other relevant documents in English.
Why Boehringer Ingelheim?
With us, you can grow, collaborate, innovate, and improve lives. We offer challenging work in a supportive and friendly environment, alongside development opportunities tailored to your role. As a company, we embrace diversity and inclusion, respecting a wide range of perspectives and backgrounds.
For more information about Boehringer Ingelheim and to apply, visit Boehringer Ingelheim Careers.
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