Lilly Business Integrator – Data Integrity in Indianapolis, Indiana
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.
The MQ IDS Data Integrity (DI) Business Integrator will partner with the IPM Site Data Leader to implement the data integrity culture and strategy for site IDS ensuring compliance with regulatory requirements for local and global systems used at the site.
This role will collaborate within the organization and externally to enable best practices and new points for consideration to enable digitization of paper-based systems.
MQ IDS Site DI Business Integrator will be responsible for the implementation of the data integrity culture and strategy for site IDS ensuring compliance with global and local regulatory requirements for systems used at the site (both local and global).
Coordinate the technical evaluation of new and existing systems from a validation and data integrity perspective.
Develop the Site Paperless strategy and execution plan to enable digitalization of paper-based systems.
Lead the implementation of technology solutions across the site to improve data integrity compliance.
Collaborate internally and externally to enable best practices and new points for consideration to improve technology use at the site.
Partner with the IPM Site Data Leader to lead the gap analysis and remediation efforts of policies associated with Data Integrity related to Good Documentation Practices and Computer Systems Validation.
Represent site MQ IDS in Data Integrity related deviations and CAPAs
Provide support in the event of internal, external and regulatory audits.
Partner cross-functionally with site Data Integrity SMEs to ensure a common, systematic approach to meeting existing and new Data Integrity expectations. This includes, but is not limited to, audit trail management, workstation security and connecting stand-alone equipment.
Bachelor’s Degree in Business Administration with Major in Information Systems, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or related field.
5 years experience working in a regulated industry (i.e. GMP) and strong understanding of quality processes in IT applying to manufacturing and distribution.
Ability to communicate effectively in written and verbal form (in English), with proven success at delivering key messages to both management and peers across multiple business functions
Demonstrated proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment.
Demonstrated ability to interpret and apply standards to different situations by understanding site needs and applying good problem-solving skills.
Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership.
Strong knowledge and technical expertise in areas of cGMPs, processes, production practices, and quality systems.
Recognized understanding of regulations governing data integrity.
Ability to build relationships across dimensions of difference, ask questions & invite others to contribute.
Speak up with ideas as well as concerns and ensure the psychological safety of others.
Demonstrated learning agility and ability to think creatively; try new ideas and apply learnings.
Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
Strong collaboration with colleagues at all levels.
Demonstrated courage & integrity.
Demonstrated success in influencing without authority.
Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
Highly flexible, adapting to changes in priorities, requirements and processes is required. Effective conceptualization, pattern recognition and teaming skills.
Business acumen, and the ability to communicate to executives, business domain stakeholders and technical staff alike.
Demonstrated influence, communication, presentation, and facilitation skills.
Experience with innovation and ideation methods, such as design thinking.
System integration experience, including interface design, and familiarity with web-oriented architecture techniques.
Understanding of common information architecture frameworks and information models.
Strong experience managing multiple concurrent initiatives and projects with aggressive timelines.
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 ( LillyRecruitingCompliance@lists.lilly.com ) 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!