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 39,000 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 Quality Data Integrity Professional (Specialist/Engineer) works independently within Lilly cross-functional groups to build Quality and Data Integrity principles into paper based and computer systems life cycle processes. Additionally, this role will partner with functional area Data Integrity leads and collaborate with QA Compliance leadership to anticipate and resolve key Data Integrity issues while driving solutions that impact the site. This role will leverage a deep understanding of GMP data flows (electronically and paper), the application of Data Integrity principles in MFG/FUME/Lab processes, and computer system development/validation methodologies to ensure regulatory compliance consistency, and sustaining of Data Integrity related activities across GMP areas. Further, this role will be responsible for developing Data Integrity training content and leading the efforts to provide such training to site Quality representatives (including Business QA, Computer Systems QA, etc.).
Perform day-to-day activities, including:
Own the responsibility for building/sustaining Quality and Data Integrity principles into computer system life cycle processes working in collaboration with QA Compliance leadership
Own DI compliance in Quality and implement DI improvement plans
Provide training, coaching, feedback and mentoring to Quality personnel on DI principles/regulations
Participate in the design and delivery of learning opportunities for Quality personnel with the purpose of strengthening the Quality/DI Culture (leveraging the network of functional DI SMEs/DI Champions).
Serve as a site quality representative on global DI-related forums, providing feedback to the site for opportunities or concerns
Represent Quality as a member on the site Data Integrity governance committee
Develop deep knowledge of system design and intended use in GMP operations to assess DI user requirements.
Perform and facilitate Data Life cycle Process Maps to identify DI risks and define mitigation strategies.
Perform, facilitate and support DI improvements to documents, systems and processes.
Lead or take part in Quality walk through, internal audits, etc. (proving technical input and system design awareness) to ensure systems are used/maintained in a state of control. Create DI-related actions and lead efforts to implement such actions.
Create, track and communicate DI-related KPIs and metrics, trending Quality-related DI deviations with the business and identify areas of concern and opportunity .
Support the assessment and effectiveness checks of Quality records (Change Controls, Deviations, Trends, etc.) for Data Integrity impact where appropriate.
Serve as a SME for DI-related inquiries / training.
Ensure Data Integrity readiness for regulatory authority inspections and participate in such inspections as necessary.
Ensure compliance with applicable Lilly global standards and regulatory guidelines.
Continuously improve Data Integrity knowledge-base and understanding.
REQUIRED KNOWLEDGE, SKILLS & EDUCATION:
BA/BS degree in the sciences, engineering, or related field with a minimum of 5 years of experience preferred in GMP operations within the Bio-pharmaceutical/Pharmaceutical industry.
Previous technical experience related to computer systems validation, system/software development life cycle, GAMP, 21 CFR Part 11 compliance, and data integrity controls in a GMP regulated environment.
Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.
Possesses a strong understanding of IT system design, controls, usage and Data Integrity requirements/regulations.
Experience in conducting data integrity assessments of current-state practices, procedures, system functionality, including but not limited to physical/logical security, ER/ES, audit trails, data mapping, record storage/retention, computer system validation, infrastructure qualification, data back-up/restore/archival, investigation, and training programs.
Must have experience leading small/medium sized projects.
Must have the ability to function in a fast-paced, cross-functional environment and communicate effectively with management.
Will be required to complete the global CSQA Qualification Program.
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 ( Lilly_Recruiting_Compliance@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.