Senior Quality Specialist, Supplier Quality

Role: Senior Quality Specialist, Supplier Quality, ensuring suppliers and contract manufacturers comply with quality, regulatory, and compliance standards in biopharma manufacturing. Responsibilities: manage SCARs and supplier change notifications, conduct cross-functional assessments, oversee quality agreement lifecycle, establish and monitor supplier KPIs, support regulatory inspections, and maintain compliance with cGMP, 21CFR, USP, EP, and ICH standards. Requirements: Bachelor's in science, 8+ years in pharmaceutical/biotech quality with 4+ years in supplier quality, strong knowledge of FDA, EMA, ICH, and GxP regulations, excellent communication, and attention to detail. Preferred: experience with electronic document management systems, CSQP certification, proficiency in relevant software tools, and ability to work independently in a fast-paced environment. High-value details: role supports pharmaceutical development and commercialization, emphasizing quality oversight of external manufacturing and testing vendors, with a focus on maintaining compliance in regulated biopharma environments. Location/Setup: not specified.