Senior Specialist Compliance Excellence (m/f/d)

ph3Responsibilities /h3ullibEnd‑to‑End Compliance Issue Resolution: /bbrLead and drive resolution of complex GMP quality notifications (QNs), investigations, impact assessments, and CAPAs within area of responsibility, ensuring timely and high-quality closure.brApply risk‑based thinking and sound GMP judgment to analyze and resolve non‑standard issues, escalating when required.brSupport and contribute to robust root cause analysis and sustainable CAPA definition. /lilibChange Risk Management: /bbrManage and support GMP product‑related change controls and risk records, ensuring compliant and efficient execution.brApply quality risk management principles to manufacturing, technical, and facility topics.brProvide input into risk assessments and change strategies. /lilibOperational Support Decision Enablement: /bbrProvide first‑line compliance support for production troubleshooting, investigations, and cross‑functional alignment.brSupport Manufacturing teams in resolving issues while maintaining GMP compliance.brEscalate complex or high‑risk decisions with clear recommendations. /lilibPerformance Management Compliance Excellence: /bbrSupport monitoring and tracking of KPIs related to quality, compliance, and operational performance.brDrive continuous improvement through data analysis, trend evaluation, and operational excellence tools such as Gemba and 5S.brIdentify and implement improvements within area of responsibility. /lilibInspection Readiness Quality Systems: /bbrSupport inspection readiness activities, including ensuring compliance of GMP documentation, deviations, investigations, and changes.brParticipate in preparation for internal and external audits and regulatory inspections.brRepresent functional area during audits or inspections as subject matter expert when required. /lilibFacility / Engineering Interface: /bbrPerform GMP impact assessments related to facility, equipment, and engineering changes within assigned scope.brCollaborate with Engineering and Facility Management to ensure compliant execution of projects and operational readiness. /lilibProject Leadership Collaboration: /bbrLead small to mid‑scale compliance or quality improvement projects with minimal to moderate complexity.brAct as project lead or workstream lead, coordinating cross‑functional contributors.brBuild strong working relationships across Manufacturing, Quality, Engineering, and Tech Transfer.brCoach and guide junior team members and support knowledge sharing. /li /ulh3Qualifications /h3ullibRequired Qualifications: /b Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline. Solid experience in GMP‑regulated biologics manufacturing with strong knowledge of compliance and quality systems. Proven ability to solve complex problems and lead investigations with minimal guidance. Experience working cross‑functionally with Manufacturing, Quality, Engineering, and Tech Transfer. Strong communication skills in German and English with the ability to influence within project teams. /li /ulh3Required Skills /h3ulliAdaptability /liliChange Control Processes /liliCustomer‑Oriented /liliDeviation Management /liliEngineering Standards /liliGood Manufacturing Practices (GMP) /liliMaintenance Engineering /liliManufacturing Process Validation /liliProcess Optimization /liliRegulatory Compliance /liliRoot Cause Analysis (RCA) /liliStrategic Thinking /liliTeamwork /liliTechnical Support /liliTechnical Transfer /li /ul /p #J-18808-Ljbffr