Sr. Principal Associate - QA Operational Readiness

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  The Sr. Principal Associate - QA Operational Readiness is a key site quality leader responsible for ensuring quality readiness of the Houston site as it transitions from project phase to GMP operations. This role provides end-to-end quality leadership to ensure that facilities, utilities, equipment, systems, processes, and teams are inspection-ready, compliant, and capable of sustained GMP execution at startup and beyond. The role partners closely with Project, Engineering, Operations, TSMS, Regulatory, and Global Quality to embed quality into design, qualification, operational readiness, and execution. The Quality Operational Readiness Lead drives risk-based decision making, governance, and alignment to ensure startup activities meet regulatory, quality, and patient safety expectations while supporting on-time delivery.

Quality Readiness Strategy Define and drive the site Quality Operational Readiness strategy to ensure GMP compliance, inspection readiness, and successful regulatory approval. Ensure quality requirements are embedded into design, qualification, validation, and startup activities. Cross-Functional Alignment Partner with Project Management, Engineering, Operations, TSMS, Regulatory, and Global Quality to align quality readiness activities with project milestones and startup timelines. Act as the primary quality interface for site readiness governance. Quality Systems Establishment Partner with other stakeholders within and outside the quality team, to the establish and execute the site Quality Management Systems (e.g., deviations, change control, document management, training) to support initial licensure and sustainable operations. Risk Identification and Mitigation Identify, assess, and mitigate quality and compliance risks through structured risk assessments, readiness reviews, and escalation mechanisms. Ensure timely resolution of gaps impacting startup or regulatory commitments. Execution Readiness & Performance Monitoring Define readiness metrics, dashboards, and governance routines to track progress and ensure accountability. Drive disciplined execution of quality deliverables across all startup phases. Capability Building & Leadership Support building and developing the site Quality organization through effective staffing, training, coaching, and knowledge transfer. Foster a strong “Safety First & Quality Always” mindset from project phase through commercial operations.

Bachelor’s degree in a scientific, engineering, or related discipline. 5+ years of experience in Quality within regulated GMP environments (Pharma, Biotech, or Medical Devices). Demonstrated experience supporting site startups, major expansions, or large capital projects from a Quality perspective. Strong working knowledge of GMP regulations, inspection readiness, validation, and quality systems. Additional Preferences Prior experience in greenfield or brownfield manufacturing startups. Experience working with regulatory submissions, approvals, and pre-approval inspections. Strong understanding of aseptic manufacturing, utilities, equipment qualification, and data integrity principles (preferred for parenteral facilities). Proven ability to lead through ambiguity, manage competing priorities, and make risk-based quality decisions under time pressure.