Senior Quality Systems Architect (m/f/d)

CHEPLAPHARM; Binningen; Hybrid; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

International team

Flexible working

Company pension

Training & development

Partner discounts

Zusammenfassung

CHEPLAPHARM.hr is seeking a Quality Management System professional to design and advance our global eQMS platform. You will ensure deviations, CAPA, and documentation are robust and aligned with regulatory expectations.

Lead validation efforts, maintain data integrity, and coordinate with regulatory authorities and external partners to drive continuous improvement across GxP systems. A Master’s degree is required, with 7+ years in QA/quality systems.

Qualifikationen

• Strong expertise in electronic Quality Management Systems, including validation and data integrity.
• Proven knowledge of GxP (GMP, GVP, GDP, GCP) and CSV or ISPE GAMP5.
• Experience coordinating cross-functional stakeholders and interacting with regulatory authorities.

Aufgaben

• Design and further develop the global Quality Management System, including deviations, CAPA, and documentation.
• Implement, validate, and continuously improve electronic quality systems (eQMS) and related platforms.
• Maintain and improve existing quality systems to ensure regulatory compliance.
• Coordinate cross-functional stakeholders and lead interactions with regulatory authorities and external partners.
• Analyze processes, define improvement measures, and contribute to strategic quality system development.
• Drive data integrity initiatives across quality systems.

Kenntnisse

eQMS expertise

Validation & CSV

GxP knowledge

Cross-functional collaboration

Analytical mindset

Ausbildung

Master's degree in natural sciences, pharmacy or medicine

Jobbeschreibung

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

Profil

• 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

Wir bieten

• 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.

Important note

Please be advised that a valid work permit for Germany is required for non-EU citizens. Unfortunately, applications without a valid work permit and sufficient German language skills may not be considered.