Lilly
healthcare
AssociateDirector–QualityAssuranceOperationalReadiness
“Associate Director – Quality Assurance - Operational Readiness at Lilly. Skills: Quality Assurance, Operational Readiness, GMP compliance, site startups, regulatory approval. ensuring quality readiness of the Houston site as it transitions from project phase to GMP operations. 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”
Industry & Context.
risk-based decision making; risk identification and mitigation; make risk-based quality decisions under time pressure
What They're Looking For.
Must Have
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, working knowledge of GMP regulations, inspection readiness, validation, and quality systems
Nice to Have
Prior experience in greenfield or brownfield manufacturing startups, Experience working with regulatory submissions, approvals, and pre-approval inspections, 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
What You'll Do.
ensuring quality readiness of the Houston site as it transitions from project phase to GMP operations
provides end-to-end quality leadership to ensure that facilities
and teams are inspection-ready
and capable of sustained GMP execution at startup and beyond
Define and drive the site Quality Operational Readiness strategy to ensure GMP compliance
and successful regulatory approval
Ensure quality requirements are embedded into design
and startup activities
Partner with other stakeholders within and outside the quality team
to the establish and execute the site Quality Management Systems (e. g.
training) to support initial licensure and sustainable operations
and mitigate quality and compliance risks through structured risk assessments
and escalation mechanisms
Ensure timely resolution of gaps impacting startup or regulatory commitments
Define readiness metrics
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
and knowledge transfer
Foster a “Safety First & Quality Always” mindset from project phase through commercial operations
How You'll Work.
Team & Collaboration
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
Communication Scope
Excellent communication and stakeholder management skills; ability to influence across functions and levels
Process & Methodology
site startups, major expansions, large capital projects, project milestones, startup timelines
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