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GCP DM Auditor

Employer
Boehringer Ingelheim
Location
Biberach, Germany
Salary
Competitive
Start date
12 Jan 2023
Closing date
11 Feb 2023

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.


THE POSITION


As an Auditor in our Corporate Department Quality Medicine (QM), you will perform Good Clinical Practice (GCP) audits mainly in the areas of biostatistics, clinical data management and computer systems validation (CSV) worldwide. In more detail, this includes process audits, system audits, audits at BI Operating Units, as well as at external partners, e. g. software service providers, CROs and other service providers.

Being part of the global QM organization, you are a competent partner to our business functions in leading them to innovatively deliver high quality outcomes. As we aim for excellence in quality, you will guide them to manage and oversee the quality of their work.


Tasks & responsibilities


  • Beyond performing (computerised) systems and GCP audits as described above, your responsibilities include to:
  • Plan and conduct audits scheduled with a risk-based strategy in the areas of biostatistics, clinical data management and computer systems validation (CSV) worldwide.
  • Coordinate audits performed by external auditors, facilitate preparation and oversee audit results.
  • Review audit responses in close collaboration with the compliance team.
  • Provide our business functions with guidance for quality standards as required.
  • Understand quality by design and actively contribute to drive the improvement of our auditing process.
  • Prepare for and participate in regulatory inspections.



Requirements


  • Bachelor’s degree in medicine, pharmacy, life science, or any other relevant field. Master’s degree or equivalent preferred.
  • Several years’ experience in auditing and/or experience in a senior advisory role in quality management and/or long term of professional experience in the pharmaceutical industry in a relevant medicine function (clinical data management and biostatistics) as well as CSV coupled with experience in auditing.
  • In-depth knowledge of GCP regulations and legal requirements.
  • Advanced analytical and problem solving skills with the ability to understand and break down complex issues to key aspects to comprehensively present audit results to the audience.
  • Advanced communication skills in English (verbal and in writing) and good computer skills are required; German language skills would be an asset.
  • Well-developed interpersonal skills are required. Open-minded and reliable personality, positive and agile strategic thinker being able to work independently as well as in a team.
  • Willingness to travel (inter)nationally, up to a maximum of 20%.



WHY BOEHRINGER INGELHEIM?


This is where you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area .

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.


READY TO CONTACT US?


Please contact our Recruiting EMEA Team, Tel: +49 (0) 6132 77-173173

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Company

With 47,700 employees in 103 countries, Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Since its foundation in 1885, the family-owned company has been pursuing an ambitious goal: to research and develop innovative pharmaceuticals that improve the health and quality of life of humans and animals alike

Company info
Website
Location
Binger Straße 173
Ingelheim am Rhein
55216
Germany

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