Sr./Principal Associate - Data Management QA

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 Data Management QA Rep works independently within the Lilly Lebanon cross-functional groups to build Quality and Data Integrity principles into the site GMP data life cycle processes.  Additionally, this role will partner with CSQA/ CSV Leads and collaborate with QA Compliance Leadership to anticipate and resolve key data management issues, while driving solutions that impact the site.  This role will leverage a deep understanding of GMP data flows (primarily electronically); the application of data integrity principles in Mfg/Fume/Lab processes; and computer system development/ validation methodologies to ensure regulatory compliance, consistency, and sustaining data integrity related activities across the Lilly Lebanon GMP areas.  Further, this role will be responsible for developing and maintaining data integrity training and lead the efforts to provide such training to site personnel.

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 Projects and Programs

• Understand customer, company, and Quality priorities, and support implementation goals.
• Provide linkages to partner organizations with CSV including Automation, Site Equipment Verification, Business QA, and site CSQA persons.

Grow Capabilities and Knowledge

• Mentor others in data management-related roles

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 data management.
• 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, Life Sciences, or a technology-related field OR 10+ years of relevant experience
• 1+ years of experience in Automation/QC Labs/IT, Quality, computer system validation or data integrity in the pharmaceutical industry

Additional Preferences:

• Direct experience with Computer Systems Validation (GAMP5) and data integrity basic principles (ALCOA+).
• Previous experience in GMP production environments
• Demonstrated strong oral and written communication skills.
• Strong interpersonal interaction skills
• Proven ability to influence quality peers, IT SMEs, and upper management.
• Previous experience in Business Quality Assurance and Automation

Additional Information:

• This is an on-site position in Lebanon, IN

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