Head of Operational Services (m/w/x) - Filling and Lyophilization page is loaded## Head of Operational Services (m/w/x) - Filling and Lyophilizationlocations: EMEA, DE, Marburg, CSL Behringtime type: Vollzeitposted on: Heute ausgeschriebentime left to apply: Enddatum: 12. September 2025 (Noch 14 Tage Zeit für Bewerbung)job requisition id: R-259120For our Value Stream Filling / Lyo in Marburg we are currently looking for a# # **Head of Operational Services (m/w/x)** **- Filling and Lyophilization**R-259120Fulltime / PermanentCSL Behring Marburg, the largest manufacturing site within the CSL network, is seeking a dedicated and experienced leader for the role of Head of Operational Services in the Value Stream Filling and Lyophilization. In this pivotal position, you will lead cross-functional teams and play a central role in ensuring regulatory compliance, quality assurance, and operational excellence across the Value Stream (VS). You will drive strategic initiatives focused on continuous improvement, cross-functional collaboration, and regulatory engagement, while acting as a key interface between operational teams and global functions.**The Role:*** Lead and develop cross-functional teams, including Operational Services, Detailed Manufacturing Scheduling, and Compliance, as well as subject matter experts such as MES/EDV Coordinators, Aseptic Leads, and Documentation Specialists.* Serve as Head of Manufacturing within the Value Stream (Leiter der Herstellung as defined under §14 AMG – German Medicines Act), with responsibility for reviewing and approving production protocols.* Foster talent development and cultivate a high-performance culture that inspires individuals to achieve both personal and organizational goals.* Design, implement, and maintain policies and procedures to ensure compliant manufacturing operations in alignment with cGMP, Annex 1, safety, environmental protection, and lean principles.* Oversee change control processes related to manufacturing operations and GMP documentation.* Ensure timely and thorough deviation investigations and the implementation of effective corrective and preventive actions (CAPAs).* Maintain continuous cGMP compliance by implementing robust procedures and monitoring their effectiveness.* Represent the Value Stream as a Subject Matter Expert during internal, customer, and regulatory audits.* Lead the evaluation of inspection outcomes, drive the execution of CAPAs, and ensure timely communication with regulatory authorities.* Conduct and oversee GxP training programs for Value Stream staff, covering cGMP, safety, and environmental protection.* Drive continuous improvement initiatives aimed at enhancing operational efficiency and economic performance, including optimization of throughput, yield, lot sizes, and labor utilization.* Lead the development of risk assessments and provide oversight in critical deviation investigations.* Act as a key interface to global functions and other CSL Behring Value Streams, promoting knowledge sharing and best practices.**Your Skills and Experience:**Educational Background:Degree in a relevant scientific discipline such as Pharmacy, Chemistry, Biotechnology, Biology, or Biochemistry.Industry Experience:8–10 years of experience in the pharmaceutical or biotech industry, with broad expertise across disciplines including Quality, Aseptic Operations, Process Engineering, and Regulatory Affairs.Leadership Experience:Minimum of 3 years in a leadership or team management role, with demonstrated ability to lead cross-functional teams effectively.**Core Competencies:*** Strong leadership and interpersonal skills* Proven expertise in GMP compliance, quality assurance, and regulatory inspections (e.g., FDA [CBER, CDER], Regierungspräsidium)* Experience in occupational safety and continuous improvement methodologies* Lean Six Sigma Green Belt certification preferred* Fluent in English, both written and spoken## **Was wir bieten**Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, .## **Über CSL Behring**CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über .## **Wir möchten, dass CSL so bunt ist wie die Welt, in der wir leben**Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über bei CSL.## **Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!**
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