Eli Lilly and Company
Director/Senior Director, Global Process Owner – Sterility Assurance QMS
Eli Lilly and Company, Concord, North Carolina, United States, 28027
Director/Senior Director, Global Process Owner – Sterility Assurance QMS
Join Eli Lilly and Company to apply for the
Director/Senior Director, Global Process Owner – Sterility Assurance QMS
role. Eli Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life‑changing medicines and to making life better for people worldwide.
Company Overview Eli Lilly is committed to improving health worldwide through innovative medicines and a people‑first culture. We value diversity, equity, and inclusion, and we strive to provide a safe, respectful workplace for all employees.
Position Overview The Director/Senior Director, Global Process Owner for Sterility Assurance will establish and maintain the global quality system procedural requirements for Level 2 aseptic processing controls, including simulations, barrier system management, cleaning, disinfection, technique, and training. The role provides strategic oversight, leads key projects and priorities, consults across sites, and ensures compliance with global regulations and industry best practices.
Key Objectives & Deliverables
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 implementation 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 business needs and facilitate accurate reporting and analytics.
Define common 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 process & tool knowledge.
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.
Engage in external organizations and industry groups to monitor policy changes for regulatory environments and advocate quality‑related policies and requirements.
Provide overall guidance and leadership for Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices, including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique.
Basic Requirements
10+ years’ experience in the pharmaceutical industry in roles across commercial manufacturing and/or quality supporting aseptic product manufacturing.
7+ years’ experience in parenteral manufacturing sterility assurance control systems – development, execution, operation, and continuous improvement in a highly regulated environment.
Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science‑related field.
Experience implementing and leading global Sterility Assurance programs, including Aseptic Training, Simulations, and Isolator Controls/Management.
Strong technical understanding of sterility assurance from a science and compliance perspective; current familiarity with filling technology, contamination control, Annex 1 interpretation.
Strong written and oral communication skills.
Knowledge of cGMPs, policies, procedures, and guidelines related to sterility assurance.
Responsibility for maintaining a safe work environment and supporting all HSE Corporate Goals.
Approximately 25 % travel.
Additional Preferences
Proven ability to work in a matrixed organization, leading diverse teams and influencing areas without direct authority.
Experience leading major multi‑site or global function improvement initiatives.
Strong strategic thinking and ability to execute decisions while balancing conflicting priorities.
Proficiency in addressing operational challenges through structured approaches and innovative solutions.
Ability to drive process improvements and strategic decisions via complex data analysis.
Demonstrated change agility and ability to guide others through change and ambiguity.
Excellent teamwork, interpersonal, and communication skills at all levels.
Expertise in developing scalable, standardized processes across global operations.
Demonstrated influential leadership and engagement with senior functional leads.
Strong governance capabilities and proactive management of quality and regulatory risks.
Experience managing aseptic processing programs, including global procedural requirements and training.
Close collaboration with senior technical staff in the parenteral network TSMS group for oversight of new and existing facilities.
Support inspection readiness and preparation for health authority inspections.
Support 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.), preferably Microbiology.
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, sexual orientation, disability, or any other legally protected status.
Compensation & Benefits Full‑time employees are eligible for an annual base salary ranging from $151,500 to $264,000, plus a company bonus contingent on performance, and a comprehensive benefits package including 401(k), medical, dental, vision, life insurance, vacation, and employee assistance program.
#J-18808-Ljbffr
Director/Senior Director, Global Process Owner – Sterility Assurance QMS
role. Eli Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life‑changing medicines and to making life better for people worldwide.
Company Overview Eli Lilly is committed to improving health worldwide through innovative medicines and a people‑first culture. We value diversity, equity, and inclusion, and we strive to provide a safe, respectful workplace for all employees.
Position Overview The Director/Senior Director, Global Process Owner for Sterility Assurance will establish and maintain the global quality system procedural requirements for Level 2 aseptic processing controls, including simulations, barrier system management, cleaning, disinfection, technique, and training. The role provides strategic oversight, leads key projects and priorities, consults across sites, and ensures compliance with global regulations and industry best practices.
Key Objectives & Deliverables
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 implementation 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 business needs and facilitate accurate reporting and analytics.
Define common 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 process & tool knowledge.
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.
Engage in external organizations and industry groups to monitor policy changes for regulatory environments and advocate quality‑related policies and requirements.
Provide overall guidance and leadership for Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices, including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique.
Basic Requirements
10+ years’ experience in the pharmaceutical industry in roles across commercial manufacturing and/or quality supporting aseptic product manufacturing.
7+ years’ experience in parenteral manufacturing sterility assurance control systems – development, execution, operation, and continuous improvement in a highly regulated environment.
Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science‑related field.
Experience implementing and leading global Sterility Assurance programs, including Aseptic Training, Simulations, and Isolator Controls/Management.
Strong technical understanding of sterility assurance from a science and compliance perspective; current familiarity with filling technology, contamination control, Annex 1 interpretation.
Strong written and oral communication skills.
Knowledge of cGMPs, policies, procedures, and guidelines related to sterility assurance.
Responsibility for maintaining a safe work environment and supporting all HSE Corporate Goals.
Approximately 25 % travel.
Additional Preferences
Proven ability to work in a matrixed organization, leading diverse teams and influencing areas without direct authority.
Experience leading major multi‑site or global function improvement initiatives.
Strong strategic thinking and ability to execute decisions while balancing conflicting priorities.
Proficiency in addressing operational challenges through structured approaches and innovative solutions.
Ability to drive process improvements and strategic decisions via complex data analysis.
Demonstrated change agility and ability to guide others through change and ambiguity.
Excellent teamwork, interpersonal, and communication skills at all levels.
Expertise in developing scalable, standardized processes across global operations.
Demonstrated influential leadership and engagement with senior functional leads.
Strong governance capabilities and proactive management of quality and regulatory risks.
Experience managing aseptic processing programs, including global procedural requirements and training.
Close collaboration with senior technical staff in the parenteral network TSMS group for oversight of new and existing facilities.
Support inspection readiness and preparation for health authority inspections.
Support 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.), preferably Microbiology.
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, sexual orientation, disability, or any other legally protected status.
Compensation & Benefits Full‑time employees are eligible for an annual base salary ranging from $151,500 to $264,000, plus a company bonus contingent on performance, and a comprehensive benefits package including 401(k), medical, dental, vision, life insurance, vacation, and employee assistance program.
#J-18808-Ljbffr