BioSpace
Director/Senior Director, Global Process Owner – Sterility Assurance QMS
BioSpace, Indianapolis, Indiana, us, 46262
Director/Senior Director, Global Process Owner – Sterility Assurance QMS
Join Lilly, a global healthcare leader headquartered in Indianapolis, to lead and drive our Sterility Assurance quality system for Level 2 Aseptic Processing. As a Global Process Owner, you will manage the full lifecycle of the program, from requirement definition to implementation, inspection readiness and continuous improvement, while ensuring compliance with global agency standards and supporting cross‑functional teams worldwide.
Position Overview The Director/Senior Director is responsible for establishing and maintaining the global quality system, standards, processes, trainings, and tools for Aseptic Processing. In this role you will partner with manufacturing, quality, site leadership, and IT to provide strategic oversight, governance, and communication around the Sterility Assurance program.
Key Objectives & Deliverables
Establish & maintain the global quality system for Aseptic Processing Program, enabling standardization.
Own global standards, processes, trainings, and implementation tools ensuring regulatory, industry, and company expectations are met.
Provide governance, lead improvement initiatives, and foster a robust compliance mindset.
Ensure consistent execution across the organization and monitor signals for continuous improvement.
Lead configuration & maintenance of supporting IT applications & analytical tools for accurate reporting and analytics.
Define global effectiveness & efficiency metrics and report insights for decision‑making.
Develop & mentor a cross‑functional community of SMEs to drive enhancements and deepen knowledge.
Collaborate with enterprise teams on standardised global business processes.
Serve as subject‑matter expert for inspection readiness, interact with health authorities, and draft responses.
Engage external and industry organisations to monitor policy changes and influence quality‑related regulations.
Provide overall guidance on Aseptic Process Simulation Design, Controls, and associated training.
Basic Requirements
10+ years in pharmaceutical manufacturing or quality with experience in aseptic product manufacturing.
7+ years in parenteral manufacturing sterility assurance control systems, including system development, operation, and continuous improvement.
Bachelor’s degree in Natural Science, Engineering, Pharmacy, or a related life‑science field.
Experience implementing and leading global Sterility Assurance programs (e.g., training, simulations, Isolator controls).
Strong technical understanding of sterility assurance, compliance, and current industry developments.
Excellent written and oral communication skills.
Deep knowledge of cGMPs, policies, procedures, and guidelines relating to sterility assurance.
Commitment to maintaining a safe work environment and supporting HSE corporate goals.
Approximately 25% travel required.
Additional Preferences
Proven ability to lead in a matrixed, global environment and influence cross‑functional teams.
Experience leading large multi‑site or global improvement initiatives.
Strategic thinker with the ability to balance conflicting priorities and execute strategic decisions.
Proficiency in structured problem‑solving and innovative solutions to operational challenges.
Data‑driven ability to analyse and interpret complex information for process improvements.
Agility in leading through change and ambiguity.
Strong teamwork and communication skills at all organizational levels.
Capability to develop scalable, standardised processes across global operations.
Influential leadership experience engaging senior‑level functional leads.
Decision‑making skills balanced with speed, quality, and risk to deliver business value.
Governance structuring and proactive quality risk management.
People‑management experience.
Expertise in global regulatory standards and frameworks.
Education Requirements BS/MS in a biological science (preferably Microbiology) or an engineering discipline (e.g., Microbiology, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering).
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form at
https://careers.lilly.com/us/en/workplace-accommodation
for further assistance.
Lilly is a proud 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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage range for this position is $151,500 – $264,000. Full‑time employees are also eligible for a company bonus and a comprehensive benefits program that includes 401(k), pension, vacation, medical/dental/vision, flexible spending accounts, life insurance, and various well‑being benefits.
#WeAreLilly
#J-18808-Ljbffr
Position Overview The Director/Senior Director is responsible for establishing and maintaining the global quality system, standards, processes, trainings, and tools for Aseptic Processing. In this role you will partner with manufacturing, quality, site leadership, and IT to provide strategic oversight, governance, and communication around the Sterility Assurance program.
Key Objectives & Deliverables
Establish & maintain the global quality system for Aseptic Processing Program, enabling standardization.
Own global standards, processes, trainings, and implementation tools ensuring regulatory, industry, and company expectations are met.
Provide governance, lead improvement initiatives, and foster a robust compliance mindset.
Ensure consistent execution across the organization and monitor signals for continuous improvement.
Lead configuration & maintenance of supporting IT applications & analytical tools for accurate reporting and analytics.
Define global effectiveness & efficiency metrics and report insights for decision‑making.
Develop & mentor a cross‑functional community of SMEs to drive enhancements and deepen knowledge.
Collaborate with enterprise teams on standardised global business processes.
Serve as subject‑matter expert for inspection readiness, interact with health authorities, and draft responses.
Engage external and industry organisations to monitor policy changes and influence quality‑related regulations.
Provide overall guidance on Aseptic Process Simulation Design, Controls, and associated training.
Basic Requirements
10+ years in pharmaceutical manufacturing or quality with experience in aseptic product manufacturing.
7+ years in parenteral manufacturing sterility assurance control systems, including system development, operation, and continuous improvement.
Bachelor’s degree in Natural Science, Engineering, Pharmacy, or a related life‑science field.
Experience implementing and leading global Sterility Assurance programs (e.g., training, simulations, Isolator controls).
Strong technical understanding of sterility assurance, compliance, and current industry developments.
Excellent written and oral communication skills.
Deep knowledge of cGMPs, policies, procedures, and guidelines relating to sterility assurance.
Commitment to maintaining a safe work environment and supporting HSE corporate goals.
Approximately 25% travel required.
Additional Preferences
Proven ability to lead in a matrixed, global environment and influence cross‑functional teams.
Experience leading large multi‑site or global improvement initiatives.
Strategic thinker with the ability to balance conflicting priorities and execute strategic decisions.
Proficiency in structured problem‑solving and innovative solutions to operational challenges.
Data‑driven ability to analyse and interpret complex information for process improvements.
Agility in leading through change and ambiguity.
Strong teamwork and communication skills at all organizational levels.
Capability to develop scalable, standardised processes across global operations.
Influential leadership experience engaging senior‑level functional leads.
Decision‑making skills balanced with speed, quality, and risk to deliver business value.
Governance structuring and proactive quality risk management.
People‑management experience.
Expertise in global regulatory standards and frameworks.
Education Requirements BS/MS in a biological science (preferably Microbiology) or an engineering discipline (e.g., Microbiology, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering).
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form at
https://careers.lilly.com/us/en/workplace-accommodation
for further assistance.
Lilly is a proud 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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage range for this position is $151,500 – $264,000. Full‑time employees are also eligible for a company bonus and a comprehensive benefits program that includes 401(k), pension, vacation, medical/dental/vision, flexible spending accounts, life insurance, and various well‑being benefits.
#WeAreLilly
#J-18808-Ljbffr