Senior QA Compliance Specialist
Core
Maintain and strengthen the Quality Management System (QMS) and ensure GMP compliance for a pharmaceutical manufacturing site.
Role type
Senior QA Compliance Specialist
Builds
Quality Management System (QMS) and compliance programs
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Quality Management System (QMS) oversight, GMP compliance, quality event management (deviations, CAPAs, investigations), risk management, audit support, training delivery, stakeholder management
Preferred skills
Sterile manufacturing experience
Technologies
QMS documentation tools, risk assessment frameworks
Responsibilities
Lead the Deviation Review Board and approve systemic quality events, author and maintain QMS documentation, review and approve quality risk assessments, support internal and external audits and regulatory inspections, deliver training on QMS and compliance topics, identify and implement improvements to quality systems
Seniority
Senior, hands-on IC