Senior Quality Risk Management Engineer

Role: Senior Quality Engineer focusing on Manufacturing Quality Assurance within an AbbVie biopharma plant. Objectives include ensuring cGMP compliance, supporting quality investigations, managing deviations, calibration oversight, and quality improvements. Responsibilities encompass acting as site liaison for Quality Risk Management (QRM), providing SME guidance on risk assessments like FMEAs, leading QRM training, supporting management review activities, participating in validation and change control processes, and maintaining QRM documentation. Qualifications: Bachelor's in Biology, Chemistry, or Engineering; 6+ years in manufacturing, quality, or engineering roles; strong communication, problem-solving, and analytical skills; knowledge of quality systems, compliance standards, and regulations relevant to API, bulk drugs, or finished goods manufacturing. High-value specifics: experience with QRM methodologies, validation review boards, and risk-based decision-making in a biopharma manufacturing environment. Work setup: not specified, but involvement in plant QA activities suggests on-site responsibilities.