MSAT Global Process Owner for Sterilization Validation QMS

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical sterilization validation capacity across the network.

Position Brand Description:

• The mission of Technical Services/Manufacturing Sciences (TS/MS) is to provide scientific leadership and technical support for manufacturing to make medicine today and tomorrow.  
• The Sterilization Network Leader is the subject matter expert for the global sterilization program and will provide global technical leadership for projects involving the sterilization program.
• The Sterilization Network Leader will assume broad responsibility across the parenteral and API Networks in terms of ownership of global control strategies as they are implemented and executed at the various sites.
• The Sterilization Network Leader will regularly interact with peers across the parenteral and API networks, including TS/MS, QA, Regulatory and Engineering, both site and central. 
• Through this global interaction the Sterilization Network Leader will drive harmonization across the network.
• The Sterilization Network Leader should share learning and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations.
• The Sterilization Network Leader should bring a sense of curiosity broadly to the platform and new site start up events which will drive innovation in the field of sterilization technologies.
• The Sterilization Network Leader will also play a central role in technical capability built at the sites to ensure capabilities are in place to meet regulatory expectations and business objectives.

The Senior Advisor/Director, MSAT Global Process Owner for Sterilization Validation QMS is responsible for these Key Objectives/Deliverables:

• 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.

Basic Requirements:

• 10+ years’ 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’ experience in sterilization technologies – development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment.
• Bachelor’s 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’s, 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 Requirements:

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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$129,000 - $209,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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