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.

　　Organization Overview:

　　At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

　　Responsibilities:

　　Function as a CSQA / CSV SME, working with Global Facility Delivery, Lilly project staff, Global CSQA, and selected External Contracting firms to complete the detailed design of the assigned areas employing Quality by Design (QbD) and Quality Risk Management (QRM) principals and ensuring the integration of Global Quality System requirements into the design.

　　Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule

　　Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase

　　Provide technical and quality review and approval of project computer system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures

　　Provide quality oversight for the verification and qualification of the parenteral building, including review of test cases, test execution, discrepancy resolution, etc. and assure that validation artifacts follow Good Documentation Practices.

　　Assure computer systems (including but not limited to IT systems, Lab Automation, M&Q Automation) meet Lilly standards and Quality Procedures conforming regulatory expectations.

　　Assist and/or lead Data Integrity (DI) related projects for the Concord site:

　　Participate in Audit Trail Review of Computer Systems and adhere to Global Lilly Standards

　　Participate in DI Assessment of Computer Systems, Interfaces, Processes to identify any potential data vulnerabilities in the design of the systems

　　Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring of new Quality and other project staff

　　Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group

　　Manage CSQA priorities, schedules to assure timely delivery of CSQA and Lilly – Concord objectives.

　　Establish partnership with the Technology Team, system owners, business owners and provide rationale with data/ Lilly guidance / priorities, etc.

　　Resolve or escalate any compliance issues to the project, site, and Quality Management

　　Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up and ongoing quality oversight of site Computer Systems

　　Participate in self-led inspections and provide support during internal/external regulatory inspections

　　Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents)

　　Basic Requirements:

　　At least 5 years working in the pharmaceutical or medical device industry in QA or CSV roles

　　Bachelor's degree in engineering or computers preferred or Science related field

　　Additional Preferences:

　　Previous CSQA / CSV experience

　　Proficiency with GMP computer systems validation including regulations governing them

　　Demonstrated strong oral and written communication and interpersonal interaction skills

　　Demonstrated strong technical writing skills

　　Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals

　　Recognize and escalates potential long-term risk for project and Site schedule.

　　Work independently and engage with assigned business areas in operational decisions on behalf of Quality organization.

　　Previous facility or area start up experience

　　Previous experience with SAP or other inventory management systems

　　CQA certification from the American Society for Quality (ASQ)

　　Addition Information:

　　Ability to work 8-hour days – Monday through Friday

　　Ability to work overtime as required

　　Ability to travel up to 10% for meetings and coordination with global regulatory organizations

　　The position is for the Concord site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities

　　Position may require a short duration assignment of 1-3 weeks in Indianapolis (or in Durham, NC) to establish specific CSQA / Data Integrity knowledge and establish global contacts

　　This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

　　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 ( [email protected] ) 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.

　　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.

　　#WeAreLilly