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

Role Summary

Director/Senior Director, Global Process Owner – Sterility Assurance QMS. Lead global quality system requirements for Level 2 Aseptic Processing controls and programs, provide strategic oversight for global Sterility Assurance standards, and drive standardization and compliance across Lilly’s network.

Responsibilities

• Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally.
• Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations.
• Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset.
• Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
• Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
• Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
• Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
• Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
• Actively collaborate with enterprise-wide teams on standardized global business processes.
• As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
• Actively engage in external organizations and industry organizations to monitor policy changes for regulatory/external environments and advocate/influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system management.
• Provide overall guidance and leadership related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique.

Qualifications

• 10+ years‚Äô experience in the pharmaceutical industry in roles across commercial manufacturing and/or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing
• 7+ years‚Äô experience in parenteral manufacturing sterility assurance control systems ‚Äì development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment
• Bachelor‚Äôs degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field
• Experience implementing and leading global Sterility Assurance programs including Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management
• Strong technical understanding of sterility assurance and current developments across the parenteral manufacturing industry
• Strong written and oral communication skills; understanding of cGMPs, policies, procedures, and guidelines relating to sterility assurance
• Commitment to safe work environment and supporting HSE goals
• Approximately 25% travel

Additional Requirements

• Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control
• Experience leading multi-site or global functions improvement initiatives
• Strong strategic thinking with ability to balance priorities and execute decisions
• Ability to drive process improvements by analyzing complex data
• Change agility and ability to lead others through change and ambiguity
• Excellent teamwork and communication skills across all levels
• Experience developing scalable, standardized processes across global operations
• Leadership experience engaging with senior-level functional leads
• Ability to make decisions balancing speed, quality, and risk
• Experience establishing governance structures and addressing quality/regulatory risks
• People management experience
• Navigating global regulatory standards and frameworks
• Experience leading multisite improvement initiatives or standardization
• Experience managing aseptic processing programs including global procedural requirements and training
• Collaborate with senior technical staff to oversee facilities, assist with inspection readiness/management, and guide investigations with root cause/CAPA
• Support establishment of a sterility assurance network/hub in global TSMS
• Support inspection preparation and execution during health authority inspections as an expert in Sterility Assurance

Education

• BS/MS in a biological science or engineering discipline (Microbiology-preferred)