Bernhard Gotter, PhD

Bernhard Gotter has been working as Quality Manager in the Global Quality Management of Bayer AG in the Consumer Health area since 2017. During his career to date he has gained experience in supervising contract manufacturers and in the areas of quality assurance, auditing and supplier management. In the context of these activities he has led numerous audits and organised and supported regulatory inspections.

After graduating in Pharmacology and receiving a PhD in Biopharmacology, Bernhard Gotters began his professional career at Bayer AG in Grenzach-Wyhlen in 2011. One of his many tasks was to manage an FDA readiness project in preparation for the first FDA inspection at the site.

The aim of the project was to boost the level of GMP compliance in Production, Quality Control, Quality Assurance, Building and Utility Services and Materials Management to meet the FDA requirements for the manufacture of parenteral biological medicinal products.

Later on, Bernhard Gotter was responsible for supplier management and auditing at the Bayer plant in Grenzach where he carried out numerous supplier audits as lead auditor.

In 2016 he moved to Hoffmann-La Roche in the Inspection Management department, where he was responsible for the organisation, support and follow-up of inspections by authorities at the Kaiseraugst site. After his return to Bayer AG he took over the support of contract manufacturers with a focus on OTC drug production.

He is author or co-author of the following chapter of GMP Compliance Adviser:

21.F Questionnaire for preparing GMP‑inspections

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