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.
Key ResponsibilitiesQuality Readiness StrategyDefine 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 AlignmentPartner 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 EstablishmentPartner 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 MitigationIdentify, 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 MonitoringDefine readiness metrics, dashboards, and governance routines to track progress and ensure accountability. Drive disciplined execution of quality deliverables across all startup phases.
Capability Building & LeadershipSupport 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.
- 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.
- 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.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
