Associate Director, Compliance

Lead the development, implementation and management of external and internal GxP (GLP, GCP and GMP) audits. This key position is responsible for all aspects of the audit lifecycle from development of Jade’s risk-based annual audit plan to monitoring and presentation of the performance and maturity of the audit program. In addition, this individual will support due diligence supplier assessments and continuous monitoring of supplier inspection performance. Implement and deliver a risk-based and data-driven strategic audit plan. Manage all aspects of the audit lifecycle including scheduling, planning, agenda issuance, audit execution, report issuance, response evaluation, request clarification, observation report creation, timely closure and tracking of supplier audit CAPA(s), and audit closure. Ensure CAPA(s) address compliance concerns identified during audits are commensurate with observation classification, overall risk and current biologics industry practices. Position is fully remote with up to 20% domestic and/or international travel.