Director, Quality - Sterility Assurance

Job Details

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.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

139,500 - $246,400

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.

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 in this role operates cross-functionally to develop approaches and to 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 at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. This role assists sites with trouble shooting and peer reviews for significant sterility assurance topics. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This position acts as a Q functional member in the PPN governance bodies as appropriate.

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 are continuously improved.
• Assume SME leadership role within the Quality organization for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network.
• Represent Quality - Sterility Assurance on network teams (e.g., sterility assurance hub) and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites : set-up appropriate forums in order to achieve this and present case studies to site SMEs.
• Provide mentoring leadership to site SMEs to continue to build capability, particularly at the newer sites or where deep technical expertise is lacking.
• Build, maintain, and grow capability across the organization in the sterility assurance space. Prioritize knowledge development for the Q organization related to sterility assurance expertise (e.g., identify talent, define individual development plans, create education and training programs, coach, mentor). Participate in knowledge development beyond the Quality organization.
• Provide technical support to new sites / filling lines during design and start-up activities to ensure sterility assurance programs and process / product requirements are supported at these sites, particularly while the sites are in early stages of building capability.
• Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the parenteral sites.
• Write internal standards and strategy documents related to sterility assurance and microbiological topics as required. Ensure that all Q decisions taken by the PQN related to sterility assurance and microbiological related topics are documented adequately, either in Lilly internal Quality standards or strategy documents, and they are traceable.
• Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical / regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice.
• Partner with the TSMS Sterility Assurance organization to oversee and administer the sterility assurance program
• Engage in providing support during regulatory interactions such as RtQ of submissions and on-site inspections
• Define and execute the process for sharing regulatory agency observations and commitments, including discussion on implementation impact evaluation across the PPN sites. Ensure there is a tracking system for decisions and for implementation completion at the sites.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals

Basic Qualifications :

Additional Preferences :

Additional Information :

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 ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include : Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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.

WeAreLilly

Salary : $139,500 - $246,400