Associate Director, Quality Systems and Compliance

Jobtailor; New York (NY); On-site; USD 170,000 - 250,000; Full time

Job summary

Jobtailor in New York seeks a senior leader to own the Quality Management System (QMS), document control, and training in a biotech setting. You will serve as the eQMS SME, ensuring system performance, compliance, and continuous improvement across SOPs, records, and training programs.

You will partner with QA, Regulatory Affairs, Manufacturing, and Clinical Development to drive quality system effectiveness, manage audits, and mentor Quality Systems staff in a culture of accountability and

Qualifications

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred
• 10+ years of Quality Assurance in regulated biopharma environments
• Experience managing enterprise Quality Systems in a GxP environment
• Proficiency with ZenQMS administration, configuration, workflow, reporting
• Experience developing and managing SOPs and controlled documentation
• Experience leading GxP and non-GxP training programs

Responsibilities

• Provide strategic leadership and operational oversight for QMS, Document Control, and Training functions
• Serve as owner and SME for eQMS ensuring performance, compliance, and improvement
• Lead SOPs, work instructions, policies, and quality records lifecycle management
• Oversee document control including issuance, revision, archival, and review
• Manage training programs ensuring timely assignment, completion, and effectiveness
• Develop quality metrics and dashboards to monitor system performance
• Partner with QA, Regulatory, Manufacturing, Clinical Development and others to ensure effectiveness
• Support audits and regulatory inspections related to Quality Systems, documentation, and training
• Ensure alignment with FDA, EMA, ICH, and global requirements
• Lead and mentor Quality Systems personnel and foster compliance culture

Skills

Quality leadership

QMS management

eQMS administration

SOP development

Training programs

Audits

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred

Tools

ZenQMS

Job description

• 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