Lilly is investing $4.5 billion to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The Foundry CSQA Associate will be responsible for the oversight of several computer systems used by Foundry to provide patients with clinical trial materials, ensuring compliance with current computer systems validation expectations.
Requirements
- Previous experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.).
- Experience supporting equipment with automation.
- Previous experience supporting cGMP API/drug substance manufacturing
- Proficient with data collection/analysis systems (e.g. Power Apps, Power Automate, SQL, Python, Tableau, PowerBI, etc.).
Responsibilities
- 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, interpretation, and ensure adherence to local procedures, Lilly and Global standards and regulatory expectations, as applicable.
- Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans.
- Participate in self-inspections, audits, supplier assessment activities to ensure the state of qualification/validation is clearly and accurately understood.
- Review and approve applicable procedures 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.
- Work with local business partners to influence and oversee the Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of new and existing 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 root cause analysis and establishment of effective CAPA to prevent reoccurrence.
Other
- Complete the corporate computer systems quality assurance qualification process.
- Work as part of a small team that ensures all the locally owned computer systems used within the Foundry are compliant with current computer systems validation expectations.
- Coordinate with the Foundry QA data integrity team to ensure evolving data integrity expectations are implemented in a sustainable manner.
- Develop solutions for Foundry QA by enhancing coordination, supporting timely decisions, and improving communications across teams.
- Work with local business partners to foster a culture of quality.
