Lilly
Director, Quality - Sterility Assurance
Lilly, Indianapolis, Indiana, us, 46262
Lilly Director, Quality - Sterility Assurance Indianapolis, Indiana Apply Now
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 to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We’re looking for people who are determined to make life better for people around the world.
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.
The purpose of this position is to act as a subject matter expert for sterility assurance and microbiology within the Quality organization. This individual operates cross-functionally to develop approaches and drive harmonization of practices in the parenteral network (PPN). The sterility assurance director drives the development of sterility assurance knowledge in the PPN sites, ensuring technical capability to meet business objectives. This role assists sites with troubleshooting and peer reviews for significant sterility assurance topics and influences peers within Lilly globally and at the site level to ensure strategies align with technical, quality, and regulatory guidance.
Responsibilities:
Operate cross-functionally to develop approaches and drive harmonization projects across the parenteral network for sterility assurance and microbiological related topics.
Work closely with site and cross-functional SMEs to drive cohesion.
Ensure control strategies are robust, consistent with regulatory and compliance expectations, and continuously improved.
Assume SME leadership role within the Quality organization for a specific topic area within Sterility Assurance across the network.
Represent Quality - Sterility Assurance on network teams and other appropriate governance forums.
Provide mentoring leadership to site SMEs to continue to build capability.
Build, maintain, and grow capability across the organization in the sterility assurance space.
Provide technical support to new sites/filling lines during design and start-up activities.
Provide technical support for significant sterility assurance investigations.
Write internal standards and strategy documents related to sterility assurance and microbiological topics.
Benchmark industry trends and emerging regulatory guidance/requirements.
Partner with the TSMS Sterility Assurance organization to oversee and administer the sterility assurance program.
Engage in providing support during regulatory interactions.
Define and execute the process for sharing regulatory agency observations and commitments.
Responsible for maintaining a safe work environment.
Basic Qualifications:
BS Degree required.
MS/PhD in a biological science preferred.
10+ years’ experience in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles.
10+ years' experience in parenteral manufacturing sterility assurance control systems.
Deep technical understanding of sterility assurance, from a science and compliance perspective.
Additional Preferences:
Proficiency in data analysis, attention to detail, and critical decision-making skills.
Strong written and oral communication skills.
Ability to mentor and develop scientists in the fields of sterility assurance.
Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance.
Experience influencing site and network leaders to advance technical agenda projects.
Additional Information:
Approximately 25% travel to connect with sites and CMOs, lead workshops across the network, and participate in PPN meetings.
Lilly is dedicated to helping individuals with disabilities engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of any legally protected status.
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Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.
The purpose of this position is to act as a subject matter expert for sterility assurance and microbiology within the Quality organization. This individual operates cross-functionally to develop approaches and drive harmonization of practices in the parenteral network (PPN). The sterility assurance director drives the development of sterility assurance knowledge in the PPN sites, ensuring technical capability to meet business objectives. This role assists sites with troubleshooting and peer reviews for significant sterility assurance topics and influences peers within Lilly globally and at the site level to ensure strategies align with technical, quality, and regulatory guidance.
Responsibilities:
Operate cross-functionally to develop approaches and drive harmonization projects across the parenteral network for sterility assurance and microbiological related topics.
Work closely with site and cross-functional SMEs to drive cohesion.
Ensure control strategies are robust, consistent with regulatory and compliance expectations, and continuously improved.
Assume SME leadership role within the Quality organization for a specific topic area within Sterility Assurance across the network.
Represent Quality - Sterility Assurance on network teams and other appropriate governance forums.
Provide mentoring leadership to site SMEs to continue to build capability.
Build, maintain, and grow capability across the organization in the sterility assurance space.
Provide technical support to new sites/filling lines during design and start-up activities.
Provide technical support for significant sterility assurance investigations.
Write internal standards and strategy documents related to sterility assurance and microbiological topics.
Benchmark industry trends and emerging regulatory guidance/requirements.
Partner with the TSMS Sterility Assurance organization to oversee and administer the sterility assurance program.
Engage in providing support during regulatory interactions.
Define and execute the process for sharing regulatory agency observations and commitments.
Responsible for maintaining a safe work environment.
Basic Qualifications:
BS Degree required.
MS/PhD in a biological science preferred.
10+ years’ experience in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles.
10+ years' experience in parenteral manufacturing sterility assurance control systems.
Deep technical understanding of sterility assurance, from a science and compliance perspective.
Additional Preferences:
Proficiency in data analysis, attention to detail, and critical decision-making skills.
Strong written and oral communication skills.
Ability to mentor and develop scientists in the fields of sterility assurance.
Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance.
Experience influencing site and network leaders to advance technical agenda projects.
Additional Information:
Approximately 25% travel to connect with sites and CMOs, lead workshops across the network, and participate in PPN meetings.
Lilly is dedicated to helping individuals with disabilities engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of any legally protected status.
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