Senior CSV Quality Assurance Specialist (f/m/d)

In this role you ensure GMP compliance for computerized systems through risk-based CSV, DI guidance, and inspection readiness. You’ll support manufacturing, packaging, labs, and logistics while driving standardisation and QMS improvements. You help manage data integrity and regulatory alignment across global governance forums. This is a hands-on, cross-functional position with a clear impact on product quality and compliance. You join a mission-driven, research-focused biopharma company advancing health solutions worldwide.

• Flexible working hours
• Company pension scheme
• Hybrid working model
• 30 days holiday entitlement
• Target bonus
• Internal training and promotion opportunities

• Provide quality oversight for GMP computerized systems and data integrity across manufacturing and related areas
• Act as change driver within the global QMS and approve quality-related documents and deviations
• Lead strategic initiatives to standardise GMP environments and represent DDQ in governance meetings
• Promote awareness of cGMP and DI, support training on CSV, data integrity, and internal procedures
• Collaborate with business units to resolve regulatory non-conformances and drive improvements locally and globally
• Represent DDQ in site and above-site meetings as needed

• Bachelor's degree
• 5+ years of delivering validated IT solutions or application support
• Strong knowledge of CSA, Annex 11, Annex 22, GAMP5 and FDA/EU/ICH regulations
• Experience implementing quality systems in pharma/lab/biotech environments
• Strong analytical, communication, and teamwork skills; ability to manage changing priorities
• Project management experience and a track record of delivering quality deliverables
• Extensive experience with deviations, CAPA, change control, MDM, qualification/validation, and inspection readiness in a GxP environment
• Excellent German and English communication skills

• strong communication
• teamwork
• problem-solving
• Data Integrity
• CSV/QA in regulated environments
• GxP, cGMP compliance