Associate Director, Quality Assurance

Role: Associate Director, Inspections, leading quality oversight for regulatory inspections and Health Authority reporting at a biopharma manufacturing site. Responsibilities: develop and implement compliance programs ensuring inspection readiness, oversee site regulatory interactions, lead inspection coordination, monitor compliance risks, and drive continuous improvement. Requirements: BS/MS with 10+ years in biotech or vaccine quality assurance, deep knowledge of cGMP, GMP regulations (e.g., 21 CFR part 11, Annex 11), and regulatory inspection experience. Preferred: prior leadership in inspection readiness, strong understanding of quality systems, CAPA, and regulatory agency engagement. HighValue: biotech/vaccine industry, regulatory inspections, site compliance, health authority reporting, GMP expertise, cross-functional collaboration, 10% travel. WorkSetup: onsite with some travel.