MSAT Global Process Owner for Sterilization Validation QMS

Role Summary

MSAT Global Process Owner for Sterilization Validation QMS

Responsibilities

• The Sterilization Network Leader will serve as technical subject matter expert for the intersection of topics related to all forms of sterilization, VPHP decontamination, and depyrogenation
• The Sterilization Network Leader will drive harmonization throughout the local Lilly sites (e.g., maintain global sterilization forums, ensure global documents are current to industry standard and agency expectations, as well as defining current gaps in global alignment and coordinating gap closure)
• The Sterilization Network Leader will be a TS/MS representative on the global change control board. This responsibility will include seeking alignment across global stewards, sites, and serving as the change control approver.
• The Sterilization Network Leader will be responsible and influential with respect to implementation of external trends and understanding how changes could impact Eli Lilly
• Technical writing and oral communication skills are used daily and the ability to effectively communicate and transfer knowledge to all levels of the organization is essential.
• Establish and maintain the global quality system for Sterilization Validation 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.

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 sterilization technologies ‚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.
• Candidate will have previous experience implementing and leading global Sterilization programs
• Strong written and oral communication skills
• Understanding of cGMP‚Äôs, policies, procedures, and guidelines relating to sterilization technologies
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
• Approximately 25% travel

Additional Preferences

• Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control.
• Experience leading a major multi-site or global functions improvement initiative.
• Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities.
• Proficiency in addressing operational challenges through structured approaches and innovative solutions.
• Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data.
• Demonstrated change agility in anticipating and leading others through change and ambiguity.
• Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.
• Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity.
• Demonstrated influential leadership expertise and experience engaging with senior-level functional leads.
• Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results.
• Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks.
• Demonstrated people management experience.
• Expertise in navigating and ensuring adherence to global regulatory standards and frameworks.
• Experience leading a major multisite improvement initiative or driving multisite standardization.
• Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training.
• Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.
• Support the establishment of a sterility assurance network or hub in global TSMS

Education

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