Sr. Associate - Computer System QA for GMP Data Integrity

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:

Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) 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, including new modalities.  This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

The Computer Systems/Data Integrity Quality Assurance role is responsible for oversite of computer system validation at the Eli Lilly Lebanon API Manufacturing facility. In addition, this role is also responsible for the definition, implementation, and maintenance of data integrity controls in GMP regulated computer systems.  This includes working with Automation, QC labs, and Tech@Lilly persons to develop validation strategies for the approach to computer system validation in compliance with corporate standards; consultation and interpretation on applying and right-sizing validation requirements; maintaining corporate and site computer systems standards and practices; participating in internal and external Regulatory agency inspections; conducting evaluations of internal or supplier quality practices; maintenance of inspectional readiness; and external benchmarking of computer system validation practices. Finally, this position will leverage an understanding of GMP data flows (electronic and paper), the application of data management/integrity principles in the site’s processes, and validation/maintenance requirements to support regulatory compliance, consistency, and sustainment.

Responsibilities:

Deliver on CSV processes and Data Integrity Sustainability

• Establish and maintain CSQ support and DI sustainability processes.

• Drive appropriate consistency in CSQ and DI controls.

Deliver Projects and Programs

• Understand and maximize business value of Data integrity controls in computer systems.

• Understand customer, company, and Quality priorities, and support implementation goals.

• Provide consulting and right-sizing of DI activities for GMP computer systems based on risk and value.

• Provide linkages to partner organizations with CSV and DI including Automation, Site C&Q, BQA, and other CSQA persons.

Grow Capabilities and Knowledge

• Mentor others in DI and CSV-related roles

• Grow capabilities of those performing DI CSV activities

Maintain Inspection Readiness

• Provide consulting and interpretation on Corporate Computer Systems/Data Integrity standards and practices as implemented at the LP1 facility.

• Provide cross-functional technical leadership in the event of serious quality-related issues with computer systems or data integrity.

• Monitor current state of inspection-readiness.

• Escalate issues appropriately.

Streamline and Continuously Improve

• Promote common process and best practice across functions.

• Identify systemic issues and trends across functions and drive improvement activity.

• Understand the external environment/best practices and bring external learning back to Lilly.

Basic Requirements:

• Bachelor’s degree in Computer Science, Engineering, Mathematics, Life Sciences, or a technology-related field

• 1+ year of experience in Automation/QC Labs/IT, Quality, or computer system validation in the pharmaceutical industry

Additional Preferences:

• Direct experience with Computer Systems Validation (GAMP5) and data integrity basic principles (ALCOA+).

• Previous experience in GMP or GLP environments

• Demonstrated strong oral and written communication skills.