Senior Manager, Deviation Management – Quality Assurance

Role: Deviation management leader supporting GMP QA/QMS functions within a biopharma setting, focusing on compliance, investigation quality, and inspection readiness. Responsibilities: establish standards for deviation investigation, triage, root cause analysis, CAPA linkage, trending, and audit preparedness; develop governance tools and KPIs; drive investigation rigor, recurrence prevention, and cross-functional performance management. Requirements: BS+ in Science or Engineering; 7-10 years in GMP QA/QMS with strong deviation and investigation expertise; proven track record of process improvement. Preferred: experience with external manufacturing networks, eQMS workflows, and continuous improvement. High-value specifics: aligns with biopharma quality systems, GMP compliance, investigation standards, and inspection readiness; may involve cross-site or CMO partner governance. Collaboration/reporting: cross-functional teams, internal and external partners, management reviews. Work setup: not specified, but likely hybrid/office based given inspection readiness and governance focus.