For our Value Stream Filling/Lyophilisation in Marburgwe are currently looking for a Head of Compliance (m/f/x) DeviationManagement R 252602 Fulltime / permanent The job incumbent is a keyplayer in the Value Stream both for critical deviationinvestigations as well as in internal, customer and regulatoryaudits. The main responsibility of the role is to proactively driveand improve cGMP compliance and a best in class Right First Time(RFT) approach (deviation and CAPA management, data trending andanalysis, training, SOPs, change control) within the respectiveValue Stream. The role might act as Compliance representative/SMEon behalf of the Value Stream in projects or other initiatives. Thecompliance to relevant Global Quality Policies should be ensuredwhile the respective SOPs and/or working instructions arecontinuously monitored to be well compliant, if necessary to berevised accordingly. Tasks & Responsibilities: Strongleadership while motivating, developing and leading the teamaccording to CSL values and principles. Leading and developing ateam of approx. 12 motivated and qualified team members Coordination of complex deviations, identifying correct root causes(RC) and smart, effective CAPAs to avoid any re occurrence ofdeviations. Compilation of deviation reports and risk assessmentsready to be approved by QA. Performing data analysis and trendingas a tool to identify potential compliance/process issues (e.g. IPCwarning limits excursions, drop in yields) in a proactive manner,as a tool to identify potential opportunities for processimprovements and/or to understand root causes of more complexcompliance/process issues to initiate an appropriate remediation. Ensuring optimal inspection readiness in the Value Stream Fill.Preparation, successful conduct and follow up of regulatoryinspections, self inspections and customer audits as required Maintaining GMP training and adequate training status to ensure acompliant production (cGMP, EHS) Might act as compliancerepresentative/SME on behalf of the Value Stream in projects orother initiatives. Initiate, coordinate and/or assessment ofchange controls. Ensure a compliant RTO (release to operation). Approval of production protocols according to 14 AMG (GermanMedicines Act) Education & Requirements: Master degree in arelevant scientific discipline (Pharmacy, Chemistry, Biology,Biochemistry) 5+ years of professional experience in thepharmaceutical/biotech industry with specific knowledge in Quality,cGMP compliance, deviation management and aseptic processesincluding 3+ years leadership/team management experience Proofedexperience in occupational safety and continuous improvementsmethods Experienced in inspection situations with authorities(e.g. US FDA, Local German Health Authorities/Regierungsprasidium) A Lean Six sigma Green Belt training isfavorable Was wir bieten Wir mochten, dass Sie sich bei CSL wohlfuhlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehrdaruber, was wi