Eli Lilly and Company
Director/Senior Director, Global Process Owner – Sterility Assurance QMS
Eli Lilly and Company, Raleigh, North Carolina, United States, 27601
Director/Senior Director, Global Process Owner – Sterility Assurance QMS
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Director/Senior Director, Global Process Owner – Sterility Assurance QMS
role at
Eli Lilly and Company .
Company Overview 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.
Position Brand Description The Director/Senior Director, Global Process Owner for Sterility Assurance is a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team. The role establishes and maintains the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. The owner provides strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems.
The Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners, and will lead key global projects and priorities within the Sterility Assurance Level 1 Program.
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 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 facilitate 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.
Serve as the subject matter expert to ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
Engage with external organizations and industry organizations to monitor policy changes for regulatory and external environments and influence quality related policies and regulatory requirements related to Aseptic Processing.
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.
Basic Requirements
10+ years 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.
Previous 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 from a science and compliance perspective, current in technologies and compliance developments across the parenteral manufacturing industry.
Strong written and oral communication skills.
Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance.
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 focus on execution 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 at all levels.
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.
Demonstrated people management experience.
Expertise in navigating and ensuring adherence to global regulatory standards and frameworks.
Experience leading a major multi‑site improvement initiative or driving multi‑site standardization.
Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training.
Support the establishment of a sterility assurance network or hub in global TSMS and inspection preparation/execution during health authority inspections.
Education Requirements BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology‑preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.).
Equal Employment Opportunity 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. 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.
Compensation Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 – $264,000. 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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Director/Senior Director, Global Process Owner – Sterility Assurance QMS
role at
Eli Lilly and Company .
Company Overview 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.
Position Brand Description The Director/Senior Director, Global Process Owner for Sterility Assurance is a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team. The role establishes and maintains the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. The owner provides strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems.
The Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners, and will lead key global projects and priorities within the Sterility Assurance Level 1 Program.
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 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 facilitate 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.
Serve as the subject matter expert to ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
Engage with external organizations and industry organizations to monitor policy changes for regulatory and external environments and influence quality related policies and regulatory requirements related to Aseptic Processing.
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.
Basic Requirements
10+ years 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.
Previous 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 from a science and compliance perspective, current in technologies and compliance developments across the parenteral manufacturing industry.
Strong written and oral communication skills.
Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance.
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 focus on execution 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 at all levels.
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.
Demonstrated people management experience.
Expertise in navigating and ensuring adherence to global regulatory standards and frameworks.
Experience leading a major multi‑site improvement initiative or driving multi‑site standardization.
Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training.
Support the establishment of a sterility assurance network or hub in global TSMS and inspection preparation/execution during health authority inspections.
Education Requirements BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology‑preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.).
Equal Employment Opportunity 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. 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.
Compensation Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 – $264,000. 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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