GCP Auditor
Boehringer Ingelheim
**The Position**
As an Auditor in our Corporate Department Quality Medicine (QM), you will perform Good Clinical Practice (GCP)-related audits across a range of functions including Clinical Development Operations, Translational Medicine, Biostatistics, and Data Management on a global scale. This includes conducting process audits, system audits, audits at BI Operating Units, investigator sites, as well as at CROs and other service providers.
Being part of the global QM organization, you will act as a trusted partner to our business functions, supporting them in delivering high-quality outcomes through innovative and compliant practices. As we strive for excellence in quality, you will guide and support these functions in managing and overseeing the quality of their work.
It is expected that the candidate has solid experience in CSV-related areas, particularly in the context of clinical systems and GCP compliance.
This position can be filled in Germany (Ingelheim or Biberach).
**Tasks & responsibilities**
In your new role, you will lead the way in planning and conducting risk-based audits across various functional areas, showcasing your expertise as a Lead Auditor.
By utilizing your keen analytical skills, you will identify potential risk areas and provide insightful assessments on the impact of audited activities.
With your expertise, you will play a pivotal role in coordinating audits performed by external auditors, ensuring seamless preparation and overseeing the audit results for maximum effectiveness.
Furthermore, you will collaborate closely with our dedicated compliance team to review audit responses, fostering a strong partnership for success.
You will act as a trusted advisor to our business functions, offering valuable guidance on quality standards and driving continuous improvement.
By designing and actively contributing to the enhancement of our auditing process, you will embrace the concept of quality and make a lasting impact on our organization.
Lastly, you will prepare for and actively participate in regulatory inspections, demonstrating your commitment to upholding the highest standards of quality and compliance.
**Requirements**
Bachelor's or master's degree in medicine, pharmacy, life science, or a related field
Several years of experience in auditing or a senior advisory role in quality management, or extensive professional experience in a relevant function within the pharmaceutical industry
Deep understanding of GCP regulations and legal requirements, as well as solid experience in CSV-related areas, coupled with advanced analytical and problem-solving skills to comprehend and simplify complex issues
Strong team and interpersonal skills with an open-minded and reliable personality paired with an independent working style. Willingness to travel (inter)nationally up to 50% of the time
Excellent communication skills in English, both verbal and written; knowledge of German would be a plus
**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 27.08.2025
Step 2: Virtual meeting period beginning from end of August
Step 3: On-site interviews beginning of September
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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