Website headcount AG
Responsible Person Germany
At headcount, we are a passionate team of scientists located in Zürich Switzerland, dedicated to finding exceptional candidates and leadership personalities for our selected clients and partners. It is our challenge to find candidates who not only meet but exceed the expectations of our partners in the pharmaceutical, biotechnology, and medical devices industry.
Our experienced and long-standing customer is continuously growing in Europe and Germany.
To meet the highest demands of the German market they are looking for an experienced personality to lead and oversee the Technical Operations and ensure Quality standards and regulations are met on the highest level.
As an expert in Quality systems, you have the exciting opportunity to take a key position for a company that is bringing cutting-edge therapies to patients that continue to suffer through less effective therapies and yet unmet needs. In this position, you will lead as a Responsible Person within an established organization where quick decisions and an open-minded culture are valued and ensure that patients profit from innovative programs and treatments developed under the highest quality standards.
- Manages and oversees all quality and pharmaceutical aspects of the local operations including full direction authority over all personnel responsible for quality and pharmaceutical measures.
- Take responsibility and ensure that all batches of medical goods comply with the requirements of the current GDP guidelines.
- Continue to train and supervise deputy RPs as required by federal law and regulations.
- Consistently improve and maintain quality systems and operations to comply with applicable GMP/GDP regulations and local regulations and specifications.
- Fulfill the responsibilities and obligations for the German entity as specified in AM-HandelsV, especially §§ 1a, 6, 7, 7a.
- Degree in life science e.g. in pharmacy, chemistry, biology, biochemistry or any related technical discipline.
- Prior experience as a Quality Responsible Person or in Quality functions in a GMP environment with experience with biologic products and small molecules in both clinical and commercial settings.
- Broad experience of GMP, GDP and German regulations (e.g. AMG)
- At least several years’ experience in a similar role in the pharmaceutical industry
- Completion of a university course of study in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, and technology, biology or a course recognized as equivalent by BfArM
- Business fluent in English and German