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. 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. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. **Role Description** Responsible for implementing and maintaining the Procedures and Document Management process. Includes Good Manufacturing Practice (GMP) library, document inventory, ensuring true copy accuracy, and overseeing document control within our electronic document system. This role also involves developing and delivering training content and providing leadership within the QA team. **Key Responsibilities:** + **Leadership:** Provide guidance and support to the QA Procedures team, fostering a culture of compliance and continuous improvement. This position includes some supervisory responsibilities. + **Document Control:** Manage document control processes within the electronic document system, ensuring timely updates and compliance with SOPs. Monitor and follow up on documents in the review and approval cycle to ensure timely progression. Monitor and follow up on documents in the review and approval cycle to ensure timely progression. + **Document Inventory Management:** Oversees the inventory of all QA documents, ensuring accurate tracking and availability. Monitor and follow up on documents in the review and approval cycle to ensure timely progression. + **GMP Library Maintenance:** Implement and ensure the GMP library is up-to-date and accessible, including the organization and archiving of documents. + **True Copy Verification:** Ensure all documents are true copies, maintaining integrity and compliance with regulatory standards. + **SOP Content Creation:** Develop and update SOPs related to GMP Library processes, ensuring clarity, compliance, and alignment with regulatory requirements. + **Training Content Development and Delivery:** Create and deliver training materials to staff, ensuring understanding and adherence to QA processes and regulations. **Basic Qualifications:** + Bachelor's degree in a related field (e.g., Life Sciences, Quality Assurance, Regulatory Affairs). + 3+ years of experience in a QA compliance role, preferably within a GMP-regulated environment. **Additional Preferences:** + Strong knowledge of GMP regulations and document control processes. + Experience with electronic document management systems. + Excellent organizational and communication skills. + Proven ability to develop and deliver effective training programs. + Leadership experience and the ability to work collaboratively within a team. + Strong organizational and time management skills. + Excellent communication and interpersonal skills. + Proficiency in document management systems and software. + Attention to detail and ability to work independently 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $162,800 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