Lead Specialist, QA Validation
Core
Lead QA oversight for commissioning, qualification, and validation (CQV) activities in a GMP manufacturing facility and quality control laboratories.
Role type
Senior IC Quality Assurance Validation Specialist
Builds
GMP-compliant manufacturing processes, utilities, and laboratory systems
Domain
Biotechnology / Cell and Gene Therapy / Manufacturing
Required skills
cGMP compliance, risk assessment, change control management, deviation/CAPA handling, technical writing, team leadership, regulatory knowledge (21 CFR, ICH, EU)
Preferred skills
Cell and Gene Therapy manufacturing experience, new facility commissioning expertise, Blue Mountain CMMS proficiency
Technologies
Kneat, Veeva, Blue Mountain CMMS, Word, Excel, PowerPoint
Responsibilities
Lead QA partnership for engineering CQV activities; oversee quality events for equipment upgrades and deviations; evaluate CQV change controls; liaise with project teams for schedule and milestone adherence; manage QAV personnel including contractors; support equipment relocation programs.
Seniority
Senior, hands-on IC with team management