Senior Manager, Quality Engineering

Senior Manager, Quality Engineering (GMP) accountable for the execution, administration, and continuous facilitation of the Quality Risk Management program within GMP operations. Partners with Technical Operations and cross-functional stakeholders to proactively identify, assess, document, and manage risks across the product lifecycle. Leads the administration and day-to-day execution of the GMP QRM program, facilitates structured risk assessments (e.g., FMEA) with cross-functional SMEs, and embeds risk-based decision making into product development lifecycle, technology transfer, process validation, continued process verification, manufacturing, and supply chain. Maintains risk registers, dashboards, and metrics; aligns QRM outputs with core quality systems (deviations, CAPA, change control); provides Quality input into process changes and investigations; supports regulatory inspection readiness and audits; mentors junior team members; travels up to 15% as needed. Education and Experience: Bachelor’s degree in a scientific discipline; minimum 12 years in pharmaceutical/biotech GMP QA; experience with ICH Q9, FMEA; knowledge of FDA/EMA expectations; cross-functional collaboration across Quality, Manufacturing, Regulatory Affairs, and Supply Chain.,