Associate Director – Quality Assurance - Operational Readiness

Associate Director – Quality Assurance - Operational Readiness

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. The 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.

Key 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.
• Partner with stakeholders within and outside the quality team to establish and execute the site Quality Management Systems.
• 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.

Requirements

• 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.

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.
• Proven ability to lead through ambiguity, manage competing priorities, and make risk‑based quality decisions under time pressure.
• Excellent communication and stakeholder management skills, with the ability to influence across functions and levels.
• Collaborative leadership style with the ability to balance compliance, speed, and business needs.

Compensation and Benefits

The anticipated wage for this position is $123,000 - $180,400. Full‑time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance) and a comprehensive benefit program, including company‑sponsored 401(k), pension, vacation, medical, dental, vision, prescription drug benefits, flexible spending accounts, life insurance, death benefits, time‑off and leave of absence benefits, and well‑being benefits.

EEO Statement

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.