Lead Specialist, (QA)
Core
Lead QA specialist ensuring compliance, quality oversight, and continuous improvement in a multi-product cGxP contract manufacturing facility.
Role type
Lead Specialist, Quality Assurance (QA)
Builds
compliant pharmaceutical/biologics products for customers
Domain
Pharmaceutical manufacturing / Biotechnology / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, deviation management, CAPA, change control, root cause analysis, regulatory inspection support, quality documentation review, risk assessment, cross-functional leadership
Preferred skills
eQMS experience, TrackWise proficiency, data integrity principles, GMP documentation management
Responsibilities
Provide QA oversight for manufacturing, lab, validation, and customer projects; lead complex quality events (deviations, investigations); review/approve GMP documentation; support regulatory and customer audits; drive quality improvement initiatives; mentor junior team members
Seniority
Lead Specialist, technical leadership & mentorship
