Associate Director – Quality Systems and Compliance
Job in
New York, New York County, New York, 10261, USA
Listed on 2026-07-13
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-13
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
- 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
- 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
Position Requirements
10+ Years
work experience
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