Suad Diglisic

Provide project-based advisory support on GMP quality systems, CMC strategy, regulatory readiness, and QC/QA for biologics and cell & gene therapy clients and investors.

Established and expanded QMS aligned with 21 CFR 820 and ISO 13485, led facility readiness and equipment qualification (IQ/OQ/PQ), and directed QC operations supporting IND submissions for oncology viral therapeutics.

Expanded QC capabilities and authored design-control and validation documentation while overseeing method development, stability programs, and regulatory compliance for cell and gene therapy products.

Led equipment validation, assay qualification, method transfer, and authored regulatory documentation supporting early clinical lentiviral gene therapy programs and audit readiness.

Performed QC release testing and process qualification for cGMP vector production supporting Phase I/II clinical trials, developed FACS and ELISA assays, and trained QC staff.

Managed viral and cell line propagation, performed GMP-grade viral product qualification and CoA development, and executed viral titration assays to support regulated supply chains.

Led high-risk BSL-2/3+ molecular testing and sample triage for public health programs, maintained chain-of-custody, and implemented QA/QC protocols to minimize false results.

Produced and validated high-quality nucleic acids, optimized robotic liquid handling for ELISA and qPCR workflows, and implemented repository and environmental monitoring systems for a large tissue bank.

Completed a Master of Science in Allied Health equivalent to a regional M.S. degree as evaluated by credential evaluation services.

Completed a professional-level diploma program in laboratory microbiology preparing for clinical laboratory work.