Associate Director, Quality Systems and Compliance

Provide strategic leadership and operational oversight for the Quality Management System (QMS), Document Control, and Training functions Serve as the business owner and subject matter expert for the electronic Quality Management System (eQMS), ensuring system performance, compliance, and continuous improvement Lead the development, review, approval, implementation, and lifecycle management of Standard Operating Procedures (SOPs), work instructions, policies, and quality records Oversee document control processes, including document issuance, revision control, archival, and periodic review Manage GxP and non-GxP training programs, ensuring timely assignment, completion, effectiveness, and compliance with regulatory expectations Develop quality metrics and dashboards to monitor system performance and identify opportunities for continuous improvement Partner with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, Clinical Development, and other cross-functional teams to ensure quality system effectiveness Support internal audits, external audits, regulatory inspections, and supplier audits related to Quality Systems, documentation, and training Ensure Quality Systems remain aligned with FDA, EMA, ICH, and applicable global regulatory requirements Lead and mentor Quality Systems personnel, fostering a culture of compliance, accountability, and continuous improvement Requirements Bachelor's degree in Life Sciences, Engineering, Quality, or a related scientific discipline; advanced degree preferred 10+ years of Quality Assurance experience within biotechnology, pharmaceutical, cell therapy, or gene therapy industries, including progressive leadership responsibilities Demonstrated experience managing enterprise Quality Systems in a regulated GxP environment Advanced proficiency with ZenQMS, including administration, configuration, workflow management, reporting, and user support Extensive experience developing, revising, implementing, and managing Standard Operating Procedures (SOPs) and controlled quality documentation Demonstrated expertise managing both GxP and non-GxP training programs, including curriculum development, training assignments, compliance monitoring, and effectiveness assessments #J-18808-Ljbffr Jobtailor