Associate Director – Quality Assurance - Operational Readiness

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.

The Associate Director – Quality Assurance - 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.

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.

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.

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.

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.

Define readiness metrics, dashboards, and governance routines to track progress and ensure accountability. Drive disciplined execution of quality deliverables across all startup phases.

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.
• 8+ 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.

• 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…