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.

** Key Responsibilities*
* ** 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.

** 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 (preferred for parenteral facilities).

+ 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (  ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

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