Senior Quality Risk Management Engineer
Core
Senior Quality Risk Management Engineer leading site-level QRM program deployment, risk assessments (FMEAs), and compliance with global QRM processes and cGMP regulations.
Role type
Senior IC Quality Risk Management Engineer
Builds
Risk-based decisions, validation support, and quality event investigations for manufacturing plant
Domain
Pharmaceutical manufacturing (API, Bulk Drug, Finished goods)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Risk Management (QRM) methodology, FMEA development, cGMP compliance, validation protocols, change control, risk assessment facilitation, regulatory standards knowledge
Preferred skills
Cross-functional team leadership, training curriculum design, management review metrics compilation
Technologies
None explicitly stated
Responsibilities
Serve as site liaison for global QRM processes, provide SME oversight for risk assessments, facilitate QRM training, compile QRM metrics for management review, monitor QRM program adherence, participate in validation review boards, maintain site-level QRM documentation
Seniority
Senior, hands-on IC
