Senior Principal Global Quality Systems Lead

• Provide oversight and consulting support to Global Process Owners, Communities of Practice, Area Process Owners, and network areas for interpretation, implementation, review, and approval of global quality system processes and documents
• Lead and continuously improve governance, management review, process monitoring, and prioritization across the Operational Controls pillar
• Assess, develop, and implement global quality system improvements, including standards, practices, training, implementation tools, effectiveness measures, and performance insights
• Partner across manufacturing, external supplier organizations, marketing affiliate quality operations, research and development, Clinical Supply, and other enterprise functions to manage process risks and enable standardized global business processes
• Monitor regulatory and industry developments, support inspection readiness, and engage with external organizations to maintain compliance and influence quality-related policies and requirements
• Support QMS Pillar leads for the health, management, and reporting across the Operational Controls pillar
• Align processes with business priorities, ensure compliance, and drive quality improvements

• Bachelor's degree or equivalent in a scientific field, engineering, or a related discipline
• Minimum of 7 years of direct cGMP experience
• Strong knowledge of cGMP requirements and quality systems
• Demonstrated experience in at least one relevant area or modality, such as Quality Control laboratories, cell and gene therapy, or parenteral manufacturing
• Fluent in English
• Previous experience with Quality Risk Management and global quality system governance
• Previous experience with process and equipment validation, cleaning and sterilization, GMP utilities, sterility assurance, or bioburden controls
• Detailed knowledge of U.S. and European GMPs, ICH, PIC/S, and WHO expectations
• Requires visits to manufacturing sites and ability to attend external training courses, conferences, or association meetings
• Ability to travel approximately 10%
• Additional languages are preferred
• Formal training in Lean, continuous improvement methodologies, or Quality Risk Management is preferred
• Continuing education, a master's degree or higher in a science-related field, or previous facility or area start-up experience is preferred

Demonstrates extensive expertise in cGMP compliance, quality system governance, and process improvement within the pharmaceutical or biotechnology sectors. Proficient in Quality Risk Management and regulatory standards, with a strong focus on aligning quality processes with business objectives.

• CGMP Experience
• Quality Risk Management
• Process Validation
• Lean Methodologies
• Regulatory Compliance

• Quality System Improvement
• Process Monitoring
• Training Development
• Performance Insights
• Cleaning and Sterilization
• Bioburden Controls
• Sterility Assurance
• Quality Control
• Manufacturing Oversight
• Regulatory Standards Knowledge

• Consulting Support
• Collaboration
• Communication
• Leadership
• Problem Solving

• U.S. GMP
• European GMP
• ICH
• PIC/S
• WHO
• Clinical Supply
• Manufacturing Sites
• External Training
• Quality Operations
• Process Risks