Quality Assurance for Sterility Assurance

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 35,000 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. Organization Overview: The QA Sterility Assurance Steward is a member of the Quality Assurance team and teaches, mentors, and guides on sterility assurance related matters in partnership with Sterility Assurance Subject Matter Experts and Management. This individual is responsible for the quality oversight program for aseptic operations and serves as a mentor for QA floor support and Sr. QA floor specialists in aseptic processing quality and compliance attributes. Acting as a subject matter expert for sterility assurance and microbiology, this individual operates cross-functionally and in partnership with TS/MS Sterility Assurance to improve the site Sterility Assurance related processes and programs (aseptic training/qualification, APS program, EM program, etc.). This individual is responsible for writing, reviewing and/or approving strategy documents, standards and procedures related to Sterility Assurance Programs, ensuring they are aligned with all appropriate quality standards and current regulatory and industry expectations. This individuals will participate in regulatory inspections and collaborate in site inspection readiness program and assist and advice functional leaders and Site Quality Leader and Quality Directors in investigations related to sterility assurance matters. The QA leader for Sterility Assurance drives the development of sterility assurance knowledge in the IPM site. Key Objectives/Deliverables: Teach, mentor, and guide site quality personnel on sterility assurance related matters in partnership with Sterility Assurance Subject Matter Experts and Management. Share findings, lessons learned, etc., related to Sterility Assurance matters and topics, with the QA organization to ensure continuous professional development of the organization. Lead the quality oversight program for aseptic operations, including developing training material for aseptic observation and teaching and mentoring QA floor support and Sr. QA floor specialists in aseptic processing quality and compliance attributes. Partner with TS/MS Sterility Assurance and the Learning & Development Organization to design, develop and implement the overall site training & qualification program related to aseptic operations. Support knowledge development for the Quality organization related to sterility assurance expertise (identification of technical talent, collaboration with area managers/directors to define individual development plans, education and training programs, mentoring and coaching, etc.). It is expected to participate in knowledge development on sterility assurance matters with other functions as well. Participate in site inspection readiness by preparing with SMEs Sterility Assurance topics and assist and participate during regulatory inspections and internal audits. For regulatory inspections observations related to sterility assurance and microbiological aspects, collaborate with TS/MS Sterility Assurance to define improvements and coach personnel through the implementation of those improvements. Write, review and/or approve internal standards and strategy documents related to sterility assurance and microbiological related topics, as required, ensuring they are aligned with Lilly Internal Standards, with other site standards and with current regulatory expectations and industry practices and they are compliant with cGMP and ensuring they are well articulated, based on sound scientific rationales and aligned with expected technical excellence. Assist with troubleshooting and investigations related to significant sterility assurance and/or microbiological matters. Provide advice and recommendations to the functional leaders and the Site Quality Leader and Quality Directors on microbiological and Sterility Assurance related topics. Escalate sterility assurance quality concerns, inspection risks or strategic misalignment issues to site Quality Leader and the Site Lead Team. Establish a strong communication and cross-functional team to work with the plants and TS/MS Sterility Assurance for microbiological and Sterility Assurance related topics. Provide inputs to the IPM Sterility Assurance roadmap and own topics related to Quality Assurance. Participate in the site cross-functional governance bodies (SAST) as the QA representative. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Network and benchmark with other sites to identify best practices and optimize site processes related to Sterility Assurance. Participate and represent the site quality in Network alignment working teams related to microbiology and/or Sterility Assurance, as appropriate (e.g., EM harmonization group, Aseptic Simulation Process working group, Pharmacopeial Review group, Microbiological Forum, PDA Lilly Group Meeting). Lead specific topics or teams and participate in PQN Meetings as presenter or sterility assurance expert during technical discussions. Collaborate with site SMEs participating in other Global Discussions or Networks (e.g., FUME, Global Water committee, Global engineering, etc., to share information related to Sterility Assurance topics. Basic Requirements: BSc or MSc in scientific degree: biology, microbiology, pharmacy or other scientific degrees with background in microbiology are required Experience in Sterility Assurance, Microbiological Laboratory or QA, TS/MS or Engineering in Parenteral manufacturing are required 7 years of experience in pharmaceutical industry. Experience in parenteral manufacturing or in controlled biological environment and processes is preferred Additional Skills/Preferences: Experience in parenteral manufacturing or in controlled biological environment and processes is preferred. Demonstrated successful cross-functional teamwork. Strong Influencing Skills and interpersonal and teamwork skills Excellent technical writing skills, critical thinking skills and good communication skills Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirements Additional Information: Travel (domestic and international) may be required. This role supports a 24/7 manufacturing operation, as such, off-shift and overtime hours might be required. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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. As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).