Associate Director, Quality Systems and Compliance

Job description

Role Summary We are seeking an experienced Associate Director, Quality Systems & Compliance to lead strategic oversight and continuous improvement of our Quality Management System (QMS), Document Control for Policies, SOPs, Work Instruction & forms, and GxP as well as some non GxP Training programs. This individual will play a critical role in ensuring our quality infrastructure supports the development and commercialization of innovative gene therapies while maintaining compliance with applicable global regulatory requirements. The successful candidate will be a hands-on leader with extensive experience implementing and managing electronic quality systems, developing and maintaining controlled documentation, and administering enterprise-wide training programs within a biotechnology or pharmaceutical environment. ### Primary Responsibilities - 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. ### Required Skills and Qualifications - 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 eQMS, preferably 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. ### Preferred Qualifications - Experience supporting gene therapy, cell therapy, biologics, or other advanced therapeutic products - Strong understanding of FDA, EMA, ICH, and global GxP regulations - Experience leading Quality System implementations, upgrades, or continuous improvement initiatives - Excellent communication, organizational, and project management skills - Proven ability to influence cross-functional stakeholders and lead through change in a fast-paced, growing organization