The Principal Associate - Contract Manufacturing (R 1-R 3) or Sr. Principal Associate - Contract Manufacturing (R 4) provides oversight and support to contract manufacturing operations of medical devices and combination products. The primary responsibility is to oversee the quality of the components, sub-assemblies, and finished devices manufactured at the Contract Manufacturers (CM) and supplied to Internal Lilly sites. The Quality Assurance Associate provides assistance and guidance on deviation investigations, CAPA, change control, batch release, equipment qualification, process validation, audits, complaints, design verification, and design validation. Ensure that components, sub-assemblies, and finished devices has been manufactured and released in compliance with cGMPs. Evaluate if products manufactured at the CM meet requirements for batch release. Review/approve GMP documents for C - Ms process manufacturing including: protocols, technical reports, deviations, change controls, inspection procedures and specifications, sampling plans, sort/rework procedures, and validation packages. Ensure that Root Cause Investigations (RC - Is) are complete, corrective or preventive actions are taken, and effectiveness checks are appropriate to address quality related issues at IDM and C - Ms. Provide data (inputs) for management review, monthly metrics, quarterly business reviews, site compliance reporting, and post-launch risk management reporting. Participate in Failure Modes and Effects Analysis (FMEA)Initiate and support continuous improvement projects. Assist with internal audits and supplier audits and maintain supplier management requirements. Support molding and non-molded part validation at C - Ms. Support design verification activities. Manage CM Quality Agreements and Quality Plans; ensure the expectations are monitored and met at the CM - Participate on joint process teams. Maintain knowledge and application of CM QMS to enable quicker, risk-based decisions relative to product quality. Coordinate process and design changes with assembly sites. Verify effectiveness activities. Additionally for R 3-R 4 candidates:Perform GMP reviews for internal procedures. Conduct GQS gap assessments and establish action plans with controlling mechanism for closure. Consult/work with Regulatory to assure compliance with applicable registrations and requirements. Coach and mentor cross-functional peers. Basic Requirements:Bachelor’s Degree - Preferred in STEM discipline 1 year industry related experience Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1 B, TN, O-1, E-3, H-1 B 1, or L-1. Additional Skills/ Preferences:Experience working with contract manufacturers and suppliers. Knowledge of global medical devices and combination product regulations (e.g. 21 CFR 820, 21 CFR Part 4, Part 11, ISO 13485, ISO 11608, Canadian MDR, EU Medical Devices Directive/ Regulation, JPAL, TGA, ANVISA)Knowledge of Quality System elements and their application in a manufacturing environment Experience with plastic molding/assembly operations. Experience with Outlook, Microsoft applications, Trackwise, Veeva, SAP, Darwin, and Master Control. Effective communication, interpersonal, and networking skill. Self-management skills. Strong attention to detail. Ability to work as part of a team. Problem solving skills. Meets commitments and deadlines. Ability to multi-task and manage competing priorities. Strong technical writing skills and proficiency in technical review of documents. Strong organizational, time management and planning skills. Additional Information:Ability to work in a dynamic and fast paced environment. Overtime may be required to meet business requirements. Some US and OUS travel will be required (approximately 10-25%)On call by cell phone during non-business hours. This position is located at LTC-North in IDM - The job responsibilities of this position support the technical ladder process. 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.