🚀 Director/Senior Director, Global Process Owner – Sterility Assurance QMS

Director/Senior Director, Global Process Owner – Sterility Assurance QMS

BioSpace – Location: Indianapolis, IN

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 work to discover and bring life‑changing medicines, 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.

Organization Overview

Lilly is entering an exciting period of growth and is committed to delivering innovative medicines to patients worldwide. Lilly is building a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.

Position Brand Description

The Director/Senior Director, Global Process Owner for Sterility Assurance will establish and maintain the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls. This includes Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. The Global Process Owner provides strategic oversight and expertise for global Aseptic Processing programs, including quality management system standards, practices, business processes, implementation tools, and associated IT systems. The role also leads an Aseptic Processing Program Community of Practice, supporting Global Process Leads and Area Process Owners, and drives key global projects 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 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 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.
• Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements.
• Provide overall guidance and leadership as 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’ experience in the pharmaceutical industry in roles across commercial manufacturing and/or quality in a manufacturing, validation, and/or quality role supporting aseptic product manufacturing.
• 7+ years’ experience in parenteral manufacturing sterility assurance control systems – development, execution, operation, and continuous improvement of systems in a highly regulated environment.
• Bachelor’s degree in Natural Science, Engineering, Pharmacy, or related Life Science 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 technological and compliance developments across the parenteral manufacturing industry.
• Strong written and oral communication skills.
• Understanding of cGMPs, policies, procedures, and guidelines relating to sterility assurance.
• Responsible for maintaining a safe work environment, working safely and accountable for 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 major multi‑site or global function improvement initiatives.
• Strong strategic thinking with a 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, with the ability to 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 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 major multisite improvement initiatives 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, availability for inspection readiness, and guidance to investigations, root‑cause, and CAPA development.
• Support the establishment of a sterility assurance network or hub in global TSMS.
• Support inspection preparation and execution during health authority on‑site or remote inspections as an expert in Sterility Assurance.

Education Requirements

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

Accommodation & EEO Statement

Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form (

Lilly is 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 and are open to all employees.

Compensation & Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage range is $151,500 - $264,000. Full‑time equivalent employees are eligible for a company bonus. Lilly offers a comprehensive benefits program, including retirement plans, vacation and time‑off benefits, medical, dental, vision and prescription drug benefits, flexible spending accounts, life and death benefits, and well‑being programs such as employee assistance and fitness benefits.

#J-18808-Ljbffr