For our Value Stream Filling / Lyo in Marburg we are currently looking for a

HEAD OF OPERATIONAL SERVICES (M/W/X) - FILLING AND LYOPHILIZATION

R-259120
Fulltime / Permanent
CSL 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.

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.

• 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.