Director/Senior Director, Global Process Owner – Sterility Assurance QMS

Role Summary

The Director/Senior Director, Global Process Owner for Sterility Assurance QMS will establish and maintain global quality system procedural requirements for Level 2 Aseptic Processing controls, including Aseptic Processing, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. They will provide strategic oversight for global Aseptic Processing Programs, lead a Program Community of Practice, and guide key global projects within the Sterility Assurance program. They will educate Lilly facilities and quality functions on Sterility Assurance requirements and ensure compliance with country agency standards and industry practices.

Responsibilities

• Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally.
• Own Global Standards, Processes, Practices, Trainings, and implementation tools; ensure design aligns with regulatory, industry, and company expectations.
• Provide governance, lead improvement initiatives, and foster a robust compliance mindset.
• Ensure processes are executed consistently and monitor signals to drive continuous improvement.
• Lead IT applications and analytical tools supporting the business, enabling accurate reporting and analytics.
• Define global effectiveness and efficiency metrics to drive end-to-end performance.
• Monitor performance metrics and provide insights to inform decision making and further improvements.
• Develop and mentor a cross-functional SME community to collaborate on improvements and deepen process knowledge.
• Collaborate with enterprise-wide teams on standardized global business processes.
• Ensure inspection readiness, interact with Health Authorities during inspections, and draft responses to observations as needed.
• Engage with external organizations to monitor regulatory policy changes and advocate for related Sterility Assurance requirements.
• Provide guidance on Aseptic Process Simulation Program Design and Implementation, including Cleaning, Disinfection, Barrier System Controls, and Aseptic Technique.

Qualifications

• Required: 10+ years in the pharmaceutical industry across commercial manufacturing and/or quality roles supporting aseptic product manufacturing; 7+ years in parenteral manufacturing sterility assurance control systems.
• Required: Bachelor’s degree in Natural Science, Engineering, Pharmacy, or Life Science-related field.
• Required: Experience implementing and leading global Sterility Assurance programs (Aseptic Training, Aseptic Process Simulations, Isolator Controls/Management).
• Required: Strong technical understanding of sterility assurance from science and compliance perspectives; up-to-date with industry developments (e.g., Annex 1 interpretation).
• Required: Strong written and oral communication; solid understanding of cGMPs, policies, procedures, and guidelines related to sterility assurance.
• Required: Commitment to safe work environment and HSE goals; travel approximately 25% (as needed).
• Preferred: Experience leading multi-site/global function improvement initiatives; ability to influence across matrixed organizations; strategic thinking with execution focus; data-driven decision making; change management agility; strong leadership and people management experience.

Skills

• Communication (written and verbal) and collaboration across all levels
• Strategic planning and program governance
• Process standardization and global implementation
• Data analysis and reporting for end-to-end performance
• Inspection readiness and regulatory liaison
• Aseptic processing knowledge and barrier systems management

Education

• BS/MS in a biological science or engineering discipline (Microbiology preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.).

Additional Requirements

• Approximately 25% travel