Head of Operational Services - Filling and Lyophilization (m/w/d)

Stellenbeschreibung

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

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.

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

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.

Kontakt

CSL Behring