QC Operations & Stability Leadership
Ph.D. Scientist · QC Operations, Stability & Quality Systems Leader
Leading GMP quality control operations, stability programs, and data integrity compliance for commercial biologics, cell, and gene therapy programs.
Quality is built in, not inspected in.
Katie Gerstley is a Ph.D. scientist and QC operations leader with roughly a decade of experience in GMP quality control laboratory operations, computerized system validation, and data integrity compliance across cGMP-regulated CDMO environments.
Her work spans analytical instrument and system lifecycle management, LIMS and STARLIMS administration, calibration and preventive-maintenance oversight, deviation management, change control, and CAPA — supporting commercial biologics, cell, and gene therapy programs, including IND and BLA submissions.
She leads and develops high-performing teams, serves as a subject-matter expert during FDA and EMA inspections and client audits, and partners across Quality, Manufacturing, IT, Facilities, and client organizations to keep QC operations compliant, efficient, and running without interruption.
Research areas: immunology, recombinant adeno-associated virus, gene delivery, biologics, and preclinical science.
Katie is pursuing QC operations, validation, and quality-systems leadership roles where she can combine deep scientific expertise, GMP compliance rigor, and proven team leadership to advance the reliable manufacture and testing of innovative therapies.
Katie is open to discussing QC operations, computerized system validation, data integrity, quality systems, and leadership opportunities within pharmaceutical, biotechnology, CDMO, and cell and gene therapy organizations.