Business Integrator - Quality Management

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

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. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing around the world to create new state-of-the-art manufacturing site’s and continue expanding our existing facilities to created capacity required to continue with our mission. The brand-new facilities will utilize the latest technology, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.  

The Manufacturing and Quality (M&Q) Tech at Lilly team at the Indianapolis Parenteral Manufacturing (IPM) site is actively looking for a business integrator to focus on Quality Management. Are you passionate about manufacturing excellence and applying technology to make reliable and life-saving medicines? If so, bring YOUR skills and talents to Lilly where you’ll have the chance to create an impact on the lives of patients with “Safety First and Quality Always”. 

What You’ll Be Doing:  

You will work as a business integrator in a growing organization to carry out a Data Integrity (DI) and Quality culture partnering with the Site Tech atLilly leadership team and Site Data Leader. This role is responsible for overall quality compliance and will leverage DI principles and computer system validation (CSV) methods to ensure data integrity and quality by design implementing solutions, compliance with regulatory requirements, and sustainable quality deliverables for local and global IT systems used at the IPM site. This role will consult on DI and CSV best practices, processes, service management, and risk-based quality deliverables and will have a critical part in ensuring the Tech at Lilly organization is inspection ready at all times. 

How You’ll Succeed:  

• You will provide oversight and leadership of the Quality (CSV) Management and DI roadmap for the Tech@Lilly IPM organization. Monitor execution of roadmap activities. 

• You will monitor and provide overall quality health indicators to the Tech at Lilly IPM Leadership Team on a monthly basis. (Track CAPAs, Data Change Compliance, etc.) 

• You will ensure compliance with global and local regulatory requirements for systems used at the site (both local and global). 

• You will own the site Tech at Lilly Change Management, Computer Systems Inventory, Service Management, and Inspection Readiness processes. 

• You will lead Site Impact Assessments from changes to Lilly Quality Processes/Procedures and implement changes to local procedures as appropriate. 

• You will provide consulting and technical evaluations with site Tech at Lilly subject matter experts (SMEs) of new and existing systems on DI and CSV deliverables. 

• You will bring a mindset of service management to the organization ensuring that all systems launched in production have a robust support model and are sustainable from a quality perspective. 

• Through certification, you will take on lead investigator activities for Tech@Lilly deviations. Represent site MQ Tech at Lilly in DI/CSV related deviations and CAPAs. 

• You will be a point of contact for the third-party validation and testing team and help with prioritization of their activities partnering with the Site Tech at Lilly leadership team.   

• You will partner with the Site Data Leader and site Tech@Lilly leadership to lead gap analysis and remediation efforts of policies associated with DI/CSV 

• You will provide back-room and inspection readiness support in the event of internal, external, and regulatory audits. 

• You will engage with the business and Tech at Lilly leadership to identify and drive opportunities to deliver business value. 

• You will create and/or contribute to the development of organizational change management plans to support IPM initiatives (e.g., training, communication, etc.) 

• You will assist in setting up and facilitating program-level governance for quality management processes. 

• You will be responsible for building quality and data integrity into solutions through awareness and knowledge of regulatory, legal, or quality requirements impacting the business area. 

• Through curiosity and initiative, stay abreast of latest quality standards and trends. 

• You will ensure that incident, problem, configuration, and change/release management are all done with alignment and understanding of business need. 

• By applying influence and organizational skills, you will have an opportunity to lead program implementations and be a point of contact to site for global implementations. 

What You Should Bring:  

• Experience working in a regulated industry (i.e., GMP) and strong understanding of processes in IT applying to manufacturing and quality 

• Proficiency with CSV and Data Integrity principles, and demonstrated ability to right-size validation based upon risk 

• Demonstrated knowledge of Incident management, deviation management, and change management processes. 

• Ability to communicate effectively in written and verbal form (in English), with proven success 

• Demonstrated ability to work at all levels and influence a stated direction. 

• Self-initiated. 

Basic Qualifications:  

• Bachelors in IT, Science, Technology Engineering, or related field. 

• 5+ years of IT experience, software engineering, and/or digital capabilities

Additional Information 

• 5-7 years of IT experience, software engineering, and/or digital capabilities

  • Professional experience supporting/developing IT applications/solutions. 

  • Knowledge of manufacturing operations, Manufacturing Execution Systems (MES) experience, or Pharmaceutical Industry experience. 

  • Professional experience working in a GXP, regulated environment.

• Position based in Indianapolis, Indiana 

• 8-hour days, possible after-hour support 

• On site presence minimum 4 days a week 

• Occasional travel may be required. 

• Must maintain a safe work environment, working safely and accountable for supporting all health and safety corporate and site goals.  

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 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.

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