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

Lilly • Concord, NC

73d

About The Position

The Director/Senior Director, Global Process Owner for Sterility Assurance, as a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team, will establish and maintain 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. They will provide 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. Additionally, the Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Sterility Assurance Level 1 Program. The Global Process Owner will consult with Lilly manufacturing facilities, Global and Site Quality and other functions to educate on the Sterility Assurance program requirements, and proactively ensure compliance of the Lilly Sterility Assurance program with various country agency standards, industry trends and scientific principles.

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 parenteral manufacturing sterility assurance control systems – 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 Sterility Assurance programs which can include 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 (e.g. filling technology, contamination control, Annex 1 interpretation)
• 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

Nice To Haves

• 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
• Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
• BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.), preferably Microbiology.

Responsibilities

• 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 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.
• 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 inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management.
• 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

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees