Group Head MSAT Equipment Qualification 80-100%
Core
Lead the qualification, governance, and continuous development of critical sterile manufacturing processes and technologies for drug product services.
Role type
Senior Group Head, MSAT Equipment Qualification & Process Platforms
Builds
Sterile drug product manufacturing equipment lifecycle strategies, process platforms, and single-use systems capabilities
Domain
Pharmaceutical manufacturing (sterile fill & finish)
Required skills
Sterile drug product manufacturing expertise, Equipment qualification lifecycle management, Process validation, Aseptic manufacturing technologies, GMP and regulatory compliance, Single-use systems (SUS) expertise, Cross-functional leadership
Preferred skills
People leadership and coaching, German language proficiency, Continuous improvement methodologies
Technologies
Isolator technology, H₂O₂/VHP decontamination, Thermal sterilization, Filling and closing systems, Freeze-dryers, Sterilizing filtration, Stoppering, Crimping
Responsibilities
Lead the Equipment Qualification & Process Platforms function with accountability for people, resources, and delivery; Set strategic direction for equipment qualification and process platform activities; Ensure capability and governance for critical sterile-manufacturing technologies; Provide functional leadership for Drug Product Process Platform ownership; Establish MSAT technical governance frameworks aligned with GMP; Drive strategic development and continuous improvement of the function
Seniority
Senior, hands-on IC with leadership responsibilities