metrics. Support Lean Manufacturing and Six Sigma initiatives. Identify opportunities to streamline processes... Product, or CDMO environment strongly preferred. Experience supporting FDA inspections, ISO audits, and customer audits...
partners to optimize regulatory strategies, streamline data use globally, and support both pre- and post-approval activities... site inspections, helping to prepare documentation and respond to regulatory questions. Mentor junior regulatory staff...
thorough QA inspections on final design data to ensure completeness, accuracy, and adherence to quality standards. Work... CAD templates for customer use to streamline future design activities and integration. Own layout quality, schedules...
data standards across all studies and vendors. Drive initiatives that improve data quality, streamline external data flows... comply with ICH-GCP, GCDMP, regulatory guidance, and Genmab quality standards. Support regulatory inspections, audits, root...