Senior Associate

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 worldwide 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. Were looking for people who are determined to make life better for people around the world. Responsibilities Act as the primary Lilly quality contact for all quality activities related to the start?up of a new external manufacturing relationship and/or support to existing relationships for new and established products. Provide quality support for existing products and existing external manufacturers. Ensure external manufacturers (EMs) follow appropriate quality systems as part of routine operations (e.g., change control, deviation management). Use regular visits, JPT, and other communications to help monitor and assess performance. Build and maintain good communications with EMs and awareness of issues/progress, including reporting back to Drug Product External Manufacturing Management, and respond to requests for data and information. Make regular visits to EMs to ensure current awareness of their operations and maintain a strong working relationship; produce a visit report for any trips made. Perform Lilly batch dispositions approve and provide appropriate documentation. Evaluate and manage deviations through the appropriate DPEM/local affiliate and external manufacturer quality systems, including regulatory impact. Evaluate and manage change controls through the appropriate EMEAA/local affiliate and external manufacturer quality systems, including regulatory impact. Investigate and monitor product quality complaints in conjunction with TSMS. Provide guidance to EMs on resolution of technical/quality issues in conjunction with TSMS. Manage implementation of laboratory accreditation for analytical methods, including appropriate analytical transfers. Participate in the development of Annual Product Reviews (APRs) and Periodic Quality Evaluations (PQEs) in conjunction with TSMS. Determine stability programs, manage them to plan, and perform periodic evaluation of data for products manufactured at EMs, and compare to other sites. Perform internal notification to management of quality issues where needed. Assess EM capability for direct sourcing and monitor supply of incoming materials and vendor approvals; carry out vendor audits as required. Review, revise, and maintain Product Specification Data Sheets (PSDSs), material specifications, and Quality Agreements (QAs), or maintain oversight if this responsibility lies with another Lilly site. Participate in the development of Master Batch Records, Packaging Orders, Process Validation Protocols and Reports in conjunction with TSMS and review any updates. Continuously identify areas for quality improvements (e.g., buildings, premises, personnel, training, procedures) and manage improvements through the GMP Plan process. Ensure EM is aware of any changes in quality and/or technical requirements and arrange training where appropriate in conjunction with GQAAC/TSMS. Track corrective actions and maintain the quality backlog. Build and maintain good communications with local Lilly affiliates; respond to requests for data and information. Participate in EM performance reviews (metrics, supply management). Participate in or lead joint process teams, alliance management, after action reviews, and feedback to the EMEAA Lead Team. Follow up on Global Quality Assurance Auditing & Compliance (GQAAC) audit findings, ensuring EM takes appropriate action in due time. Perform inspection and GMP assessments of distribution/warehousing premises and practices as required. Provide quality support for commercialization of new products/new EMs and for additional capacity implementation for existing products at existing EMs. Work in conjunction with TSMS, commercialization teams, regulatory teams, and Lilly sites to establish and implement plans for successful projects at EMs; provide QA guidance as needed. Assess capabilities of existing EMs to produce additional products, especially regarding quality topics (segregation, cleaning validation, staff skills, procedures, training). Assess new EMs for their level of implementation of Product Quality Systems and recommend suitability as a future partner. Ensure appropriate compliance documentation is in place, such as qualification and validation protocols, and ensure approval prior to start of manufacturing operations. Prepare Quality Agreements and maintain/improve them. Produce audit qualification reports and review process validation reports. Review, revise, and maintain DPEM Standard Operating Procedures (SOPs). Co?operate with GQAAC in the preparation of Lilly standards and implement at EMs. Provide input for monthly reports and metrics. Act as a subject matter expert within DPEM, ensuring full understanding of requirements and providing expert guidance to DPEM/external manufacturers as appropriate. Ensure the quality backlog is appropriately managed and issues are escalated as necessary. Qualifications Graduate in Chemistry, Pharmacy, or another similar technical background. Significant experience in technical and quality functions within a manufacturing plant, ideally in parenteral products (syringes and/or vials). Appreciation of cultural diversity. Willingness to travel. EEO Statement Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. Lilly 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. Application Process To request an accommodation for the application process, please complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation. This request is part of the application process and does not result in a response from Lilly for any other correspondence. #J-18808-Ljbffr