Quality Assurance Director, Operational Readiness (GMP)

Eli Lilly and Company; Houston (TX); On-site; USD 123,000 - 180,000; Full time

Job summary

Lilly, Houston site, seeks an Associate Director – Quality Assurance - Operational Readiness to lead end-to-end quality readiness as we transition to GMP operations. You will drive inspection readiness and robust quality systems across facilities, utilities, equipment, and processes.

You will collaborate with Project Management, Engineering, Operations, TSMS, Regulatory, and Global Quality to embed quality into design, qualification, and startup activities, ensuring regulatory expectations are

Qualifications

• 8+ years of experience in Quality within regulated GMP environments (Pharma, Biotech, or Medical Devices).
• 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.

Responsibilities

• Define and drive the site Quality Operational Readiness strategy to ensure GMP compliance, inspection readiness, and successful regulatory approval.
• Partner with Project Management, Engineering, Operations, TSMS, Regulatory, and Global Quality to align quality readiness activities with project milestones and startup timelines.
• Establish and execute the site Quality Management Systems (e.g., deviations, change control, document management, training).
• Identify, assess, and mitigate quality and compliance risks through structured risk assessments, readiness reviews, and escalation mechanisms.
• Define readiness metrics, dashboards, and governance routines to track progress and ensure accountability.
• Support building and developing the site Quality organization through staffing, training, coaching, and knowledge transfer.

Skills

Quality leadership

GMP knowledge

Risk-based decision making

Regulatory readiness

Education

Bachelor’s degree in a scientific, engineering, or related discipline

Job description

Lilly, Houston site, seeks an Associate Director – Quality Assurance - Operational Readiness to lead end-to-end quality readiness as we transition to GMP operations. You will drive inspection readiness and robust quality systems across facilities, utilities, equipment, and processes.

You will collaborate with Project Management, Engineering, Operations, TSMS, Regulatory, and Global Quality to embed quality into design, qualification, and startup activities, ensuring regulatory expectations are