Associate Director, GxP Quality Auditor

Role: Associate Director, GxP Quality Auditor, responsible for planning, conducting, and managing quality audits across external CDMOs, clinical sites, and internal lab operations within a biotech focused on cell therapies for autoimmune diseases. Objectives include ensuring compliance with GxP, regulatory requirements, and industry standards, supporting quality system implementation, and fostering a culture of compliance. Responsibilities encompass executing audit strategies, risk assessments, investigating non-compliance, preparing audit reports, and training staff. Requirements: Bachelor's in a scientific discipline, 5-7 years in biopharma with at least 3 years in GxP auditing, strong knowledge of GxP regulations, and experience with electronic Quality Management Systems. Preferred: auditor certification. High-value specifics include expertise in GxP compliance within cell/gene therapy, involvement in regulated environments, and experience supporting quality assurance in biotech. Collaboration involves cross-functional engagement with quality, operations, legal, and compliance teams. Location: remote; no travel specified.