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Senior Quality Systems Architect (m/f/d)
CHEPLAPHARM Arzneimittel GmbH
We are an owner-managed, globally active company in the specialty pharmaceuticals sector with a clear mission: to be THE sustainable platform for long-established and trusted pharmaceutical brand products in various therapeutic areas. As a reliable partner to the research-based pharmaceutical industry, CHEPLAPHARM ensures the availability and supply of these medicines for the global market.
This benefits not only our partners, but also patients around the world. We are proud that our specialised business model has enabled us to become one of the world's leading companies in the acquisition of original preparations within 20 years, and we continue to grow. The aspiration of our approximately 800 employees: Together, we want to ‘ACHIEVE MORE'.
- Design and further develop the global Quality Management System, including processes for deviations, CAPA, and documentation
- Implement, validate, and continuously improve electronic quality systems (eQMS) and related platforms
- Maintain and continually improve existing quality systems to ensure compliance with regulatory requirements.
- Ensure alignment with relevant international GxP regulations, such as ICH Q10, EU GMP/GVP/GCP/GDP, 21 CFR, and Regulatory regulations
- Ensure compliance with international GxP regulations and drive data integrity initiatives across quality systems
- Coordinate cross-functional stakeholders and lead interactions with regulatory authorities and external partners
- Analyze existing processes, define improvement measures, and contribute to strategic quality system development
- A Master's degree in a relevant field, i.e. generally in the natural sciences, pharmacy or medicine
- At least 7 years of relevant professional experience.
- Strong expertise in electronic Quality Management Systems, including validation and data integrity
- Expert knowledge of GxP (GMP, GVP, GDP, GCP) and computer system validation (CSV) or ISPE GAMP5.
- Proven experience in cross-functional collaboration and stakeholder management in complex environments
- Analytical and strategic mindset with the ability to drive innovation and continuous improvement in quality systems
Corporate culture & internationality
A growing company with a diverse, open working environment and employees from around 40 countries.
Flexible working models & work-life balance
Individually customisable working models, including the option to work from another EU country for up to two months per year. Working time account with compensatory time off and 30 days of holiday.
Individual benefits & pension provision
Flexible benefits budget, e.g. for increased company pension provision, fitness and health offers or subsidies for travel and meal costs.
Discounts & additional benefits
Access to the corporate benefits platform with discounts at hundreds of partner companies.
Further development & team culture
Internal and external training courses tailored to personal goals, as well as company and team events to strengthen cohesion and celebrate successes together.
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