Senior Quality Systems Architect (m/f/d)

CHEPLAPHARM; Berlin; Hybrid; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Flexible benefits budget

Career development & training

Pension provision

Travel and meal subsidies

Zusammenfassung

CHEPLAPHARM seeks a senior quality professional to design and advance the global Quality Management System (QMS) and related eQMS platforms. You will drive deviations, CAPA, and documentation processes while maintaining alignment with international GxP regulations across a multinational environment.

The role requires a Master’s degree in a relevant field and 7+ years' experience in cross-functional quality management, with strong CSV and data integrity expertise to support regulatory submissions

Qualifikationen

• Master’s degree in a relevant field (natural sciences, pharmacy or medicine).
• 7+ years of professional experience in quality management and GxP environments.
• Strong expertise in electronic Quality Management Systems (eQMS) and CSV.
• Solid understanding of GxP (GMP, GVP, GDP, GCP) and regulatory expectations.

Aufgaben

• Design and further develop the global Quality Management System (QMS).
• Implement, validate, and continuously improve electronic quality systems (eQMS) and related platforms.
• Maintain and improve existing quality systems to ensure regulatory compliance.

Kenntnisse

Quality management

GxP compliance

Crossfunctional collaboration

Regulatory knowledge

Data integrity

CSV validation

Ausbildung

Master’s degree in natural sciences/pharmacy/medicine

Tools

eQMS

CSV validation

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.

What Makes Your Day With Us Special

• 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

What Sets You Apart

• 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

What We Offer You Besides The Job

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.