Product Quality & Incident Management

• Manage product-related incidents, including out-of-specification (OOS) results, bioburden and particle issues, deviations
• Act as quality function, investigator, and/or subject matter expert for assigned cases
• Ensure timely, compliant investigations, root cause analyses, and implementation of effective CAPAs
• Functionally guide and coach more junior colleagues in team in incident handling, including investigation strategy, root cause analysis, documentation, and CAPA definition

Complaint Handling

• Oversee and handle product quality complaints in compliance with regulatory and internal requirements
• Ensure robust documentation, trending, and escalation where required

Quality Systems & Documentation

• Prepare, review, and maintain SOPs and quality-related documentation
• Support change management activities for assigned quality topics where applicable

Collaboration & Quality Support

• Serve as a subject matter expert for out-of-specification (OOS) results, bioburden and particle issues, deviations
• Provide quality oversight and guidance to cross-functional teams (e.g. Regulatory, Tech. Development)
• Proactively identify quality risks and drive mitigation strategies
• Collaborate closely with CMOs on product quality topics

Performance & KPI Management

• Support quality KPI definition, monitoring, trending, and reporting
• Contribute to continuous improvement initiatives based on operational quality data

• University degree in Pharmacy, Life Sciences, (Bio)Chemistry, Biotechnology, or a related field
• Advanced degree (MSc, PhD) or professional certification in Quality Management / GMP is an advantage
• 3 years of experience in a similar role within the manufacturing/quality department/QC of pharmaceutical industry
• Strong hands-on experience with incident management, deviations, OOS, complaints, and CAPA
• Solid understanding of GMP and regulatory expectations (EU, FDA, ICH guidelines)
• Structured, solution-oriented mindset with high attention to detail
• Experience working with CMOs, including the ability to challenge quality topics constructively in a professional manner
• Confident communicator, able to explain quality requirements clearly to internal/external partners
• Fluent in German and English (written and spoken)
• Professional technical writing skills

• An open corporate culture with the opportunity to contribute your own ideas
• Working independently in a collegial and committed team
• Modern working environment with good public transport connections (U4 - Heiligenstadt)
• Flexible working hours (flexitime/time-out days), bonus scheme, additional benefits and employee events
• Structured onboarding and support through a buddy system
• Due to legal requirements, we are obliged to disclose the collective agreement minimum salary, which is EUR 45,080 gross per year, based on full-time employment. However, our actual remuneration packages are market-oriented and aligned with your qualifications and professional experience.

If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then: Take this CHANCE!