Cory Marcera

About Cory Marcera

Senior Director quality leader with 25+ years personally building, running, and transforming quality organizations across drug product and drug substance operations — not only leading the people who do the work, but working side by side with them. When needed I write the SOPs, design the systems, lead the investigations, sit with site teams to work through deviation root causes, make batch disposition calls, and author change controls alongside the people accountable for getting product out the door. That working leader approach has been consistent across every role — from site quality head at Mallinckrodt and DPT, to clinical QA operations lead at Gilead supporting 17 cross-functional departments, to governing quality systems directly embedded across Kite\'s commercial CAR-T sites and viral vector plant, to the weekly site work I do today across Lilly\'s multimodal manufacturing network including sites actively manufacturing both API and finished drug products. My experience spans a wide spectrum of modalities — oral solid dose, cell and gene therapy, biologics, sterile injectables, ADCs, oligonucleotides, liquids, semi-solids, and small molecules — across a wide range of manufacturing environments from DEA Schedule II controlled substance production to aseptic cell therapy manufacturing. My quality philosophy centers on establishing a business enabling quality group and a comprehensive pharmaceutical quality system that positions operations for success and Quality as a business partner not an obstacle. I employ real Quality Risk Management principles, applied as the strategic lens through which every quality decision is made to understand what the organization is trying to accomplish and the constraints to find an innovative but complaint path forward. I build self-sustaining quality organizations — developing the people and leaders who own and advance quality systems independently. Six consecutive zero-finding regulatory inspections across FDA, EMA, HPRA, ANVISA, and IGJ.$9M in annual savings. 55% reduction in avoidable deviations. Zero recalls, zero market withdrawals, zero critical findings across my career. Certified Six Sigma Black Belt, LEAN training at Toyota, and trained by McKinzie as a Coach and Change Agent. Veeva Vault QMS Project Leader— 13 modules deployed. TrackWise project lead deploying 10 modules. PhD candidate in Industrial/Organizational Psychology.

Experience

1. Sr Director, Global Quality

   Eli Lilly and Company

   May 2025 — Present · Indianapolis, IN, US

   Supporting the global expansion of six new manufacturing sites spanning cell & gene therapy, ADCs, synthetic peptides, oligonucleotide, and sterile product modalities. Building quality infrastructure. Conceived and built the Greenfield Site Quality Playbook — a complete deployment roadmap from pre-construction through PAI/PLI readiness, adopted across all new Lilly sites globally.Developed multi-site SOP standardization and a global QMS alignment program to create consistency across a rapidly scaling manufacturing network.Built an integrated Quality, Capacity, and Resource Forecasting Model with Competency Matrix to enable scalable workforce planning.Led global harmonization and site readiness programs for new site licensure.Embedded Lean principles and digital quality process integration across enterprise systems — saving $450K in year-one consultant fees.

Education

• Liberty University

  Doctor of Philosophy - PhD, Industrial and Organizational Psychology

• Empire State University

  Bachelor of Science - BS, Biochemistry

• National University

  Master's Degree, Forensic Sciences