Lead Specialist, (QA)
Core
Lead QA specialist ensuring compliance, quality oversight, and continuous improvement in a multi-product cGxP contract manufacturing facility.
Role type
Senior IC Quality Assurance Specialist
Builds
compliant pharmaceutical/biologics products and quality systems
Domain
Life Sciences / Contract Manufacturing / cGMP
Required skills
cGMP compliance, deviation management, CAPA, change control, root cause analysis, regulatory inspection support, quality documentation review, risk assessment, cross-functional leadership
Preferred skills
eQMS (TrackWise), data integrity principles, GMP documentation management
Responsibilities
Provide QA oversight for manufacturing, lab, validation, and customer projects; lead complex quality events (deviations, CAPAs, investigations); review and approve GMP documentation; support regulatory and customer audits; drive cross-functional quality improvement initiatives; mentor junior team members.
Seniority
Senior, hands-on IC