Sr. Engineer, Supplier Quality

Role: Senior Engineer, Supplier Quality, responsible for managing and ensuring compliance of the GxP Supplier Quality Management Program within a biopharmaceutical GMP environment. Objectives include overseeing supplier audits, maintaining supplier quality agreements, and supporting regulatory inspections to ensure product quality and compliance. Responsibilities involve leading GMP supplier audits, managing supplier qualification and performance metrics, and collaborating with cross-functional teams for supplier selection and process improvements. Qualifications: Bachelor's in biology, chemistry, biochemistry, or chemical engineering with 5+ years of pharma/biopharma GMP experience, including at least 2 years in auditing; quality auditor certification preferred. High-Value: experience with biologics, finished goods, APIs, excipients, and combination products; familiarity with FDA, EMA, ISO, GxP, and ICH standards; strong knowledge of supplier quality processes, regulatory compliance, and audit management. Work Setup: based in Vandalia, OH; full-time with benefits and bonus potential.