Advisor - PRD QA Computer Systems QA at Eli Lilly and Company

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:
Product Research and Development (PRD) quality assurance (QA) supports the delivery of the Lilly pipeline by providing oversight of the manufacturing, packaging, and distribution of the medicines needed for clinical trials (CT).  As PRD Computer Systems Quality Assurance (CSQA) Advisor, you will be responsible for the oversight of all of the computer systems used by PRD to provide patients with clinical trial materials.  This includes automated process equipment used in on site manufacturing facilities, process historians, and a wide variety of other systems that enable clinical trial supply.

Responsibilities:

As a PRD CSQA advisor, you will be required to complete the corporate computer systems quality assurance qualification process.  You will work as part of a small team that ensures all of the locally owned computer systems used within PRD are compliant with current computer systems validation expectation.  This will include coordinating with the PRD QA data integrity team to ensure evolving data integrity expectations are implemented in a sustainable manner.  Additional specific responsibilities include:

• Coach and mentor others in aspects of computer systems validation support, including System Development Lifecycle knowledge, problem solving, project management, and documentation design.
• Provide consultation and interpretation of local procedure, Lilly and Global standards and regulatory expectations.
• Review and approve applicable procedure to ensure compliance with Lilly Quality standards and regulatory requirements.  Assess potential gaps between local procedure and Lilly and Global standards and facilitate remediation efforts.
• Influence and oversee the Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets including review and approval of associated GMP deliverables.
• Evaluate potential product quality impact for any GMP-related incident (Change Control and non-conformance), perform initial leveling, and support the investigations to ensure proper RCA and establishment of effective CAPA to prevent reoccurrence.
• Perform Quality approvals for GMP documents such as Critical Alarm Audits, Utilities Reports, Business Reviews and Periodic Quality Evaluations.
• Ensure PR&D is audit ready at all times and participate in internal/external inspections

Basic Requirements:

• Bachelor’s degree in Science, Engineering, or related field
• Previous experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.)

Additional Skills/Preferences:

• Previous experience supporting cGMP API/drug substance manufacturing
• Demonstrated strong oral and written communication skills
• Demonstrated interpersonal skills and the ability to work as part of a team
• Proven ability to envision and oversee implementation of continuous improvements
• Previous QA experience
• Proficient with data collection/analysis systems (e.g. Power Apps, Power Automate, SQL, Python, Tableau, PowerBI, etc.)

Additional Information:

• This position flexibly supports on site manufacturing activities in Indianapolis at the Lilly Technology Center North campus.
• Occasional travel (<10%) will be required for collaboration partner oversight, training, conferences, etc.
• Applicant may work in various areas/buildings within PR&D.  Some allergens maybe present. Mobility requirements and exposure to allergens should be considered when applying for this position.

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