Senior Quality Risk Management Engineer
Core
Senior Quality Risk Management Engineer leading deployment of global QRM processes, overseeing risk assessments (FMEAs), and ensuring cGMP compliance for manufacturing plant operations.
Role type
Senior IC Quality Risk Management Engineer
Builds
Risk management frameworks, validation protocols, and quality assurance documentation for manufacturing
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Quality Risk Management (QRM), Failure Mode and Effects Analysis (FMEA), cGMP compliance, Validation protocols, Root cause analysis, Regulatory standards knowledge, Change control, Cross-functional collaboration, Data analysis, Technical writing
Preferred skills
Biology, Chemistry, or Engineering background
Technologies
None explicitly stated
Responsibilities
Serve as site liaison for global QRM processes; Provide SME oversight for FMEAs and risk assessments; Deliver QRM training and guidance; Compile and present QRM metrics for management review; Monitor site QRM program adherence; Participate in global documentation changes and change control; Act as QRM SME in Validation Review Board discussions; Ensure compliance with company policies and regulations; Maintain site-level QRM documents.
Seniority
Senior, hands-on IC
