TU PRÓXIMO CAPÍTULO
Associate / Senior Associate / Principal Associate – Medicines Quality Organisation
Sobre el puesto
• Support the development, review, and approval of local quality documents, tools, and templates
• Manage deviations, change controls, and escalations, including root cause analysis and CAPA
• Provide quality oversight for functional areas, including compliance monitoring, trend analysis, and recommendations for action
• Prepare, coordinate, and support audits and regulatory inspections, including CAPA follow-up
• Serve as the primary point of contact for quality-related questions and provide risk-based advice to functional areas
• Share best practices, build a network across quality groups, and contribute to projects
• Handle sensitive information, including patient data, audits, and inspections, with the utmost confidentiality
• Advise the affiliate and/or region on quality requirements
• Integrate quality requirements into business processes and ensure consistency between global standards and local requirements
• Degree in a natural science or health-related discipline, or qualification in a healthcare profession (e.g., pharmacist, nursing professional)
• 5–10 years of experience in quality, pharmacovigilance, or regulatory affairs
• Practical experience applying quality systems in a regulated environment (GMP, GCP, GVP)
• Strong analytical thinking, attention to detail, and risk-based decision-making skills
• Persuasive communication skills and the ability to confidently prioritize multiple concurrent tasks
• Languages: fluent German and English
• Eligibility for a company bonus, depending in part on company and individual performance
• Eligibility to participate in a pension plan
• Vacation benefits
• Eligibility for healthcare benefits
• Flexible benefits (where applicable)
• Life insurance and death benefits
• Certain time-off and leave-of-absence benefits
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities
• Full-time employment
• 12-month fixed-term parental-leave replacement assignment