You lead risk-based audits and work closely with external auditors and compliance teams to ensure that quality standards are met and continuously improved while preparing for regulatory inspections.
Anforderungen
- •Bachelor's degree in medicine or pharmacy
- •Several years of experience in auditing
- •Deep understanding of GCP regulations
- •Strong team and interpersonal skills
- •Excellent communication skills in English
Deine Aufgaben
- •Plan and conduct risk-based audits.
- •Identify potential risk areas and assess impacts.
- •Coordinate audits with external auditors.
- •Review audit responses with the compliance team.
- •Advise business functions on quality standards.
- •Enhance the auditing process for quality improvement.
- •Prepare for and participate in regulatory inspections.
Original Beschreibung
# GCP Auditor
## 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