QA Senior Specialist, Risk Management
Core
Site System Owner for the Quality Risk Management (QRM) Program and Site Risk Register, driving a risk-based quality culture and ensuring compliance with GMP regulations.
Role type
Senior Specialist, Quality Risk Management (QRM)
Builds
Site-wide risk governance processes, risk registers, and management review reports
Domain
Pharmaceutical manufacturing / Biotechnology / GMP compliance
Deliverable
dashboards & analysis
Required skills
ICH Q9, FDA cGMP, EU GMP, PIC/S GMP, Risk assessment, Change control, Deviation management, CAPA, Validation, GMP quality systems
Preferred skills
None stated
Technologies
None stated
Responsibilities
Own and maintain the site QRM Program, procedures, templates, and governance processes; Facilitate and support cross-functional risk assessments for GMP operations, change controls, deviations, CAPAs, validation, facilities, utilities, computerized systems, warehouse, and QC activities; Maintain and monitor the Site Risk Register, including risk escalation, mitigation tracking, and periodic review; Provide site-level risk trending, dashboards, metrics, and management review reports to Quality and Site Leadership; Lead QRM training, coaching, and awareness programs across the site; Support regulatory inspections, customer audits, and corporate assessments as the QRM SME.
