Head Of Operational Services (m/w/x) - Filling And Lyophilization

Head of Operational Services (M/W/X) - Filling and Lyophilization

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.

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