Director, Quality Systems & Compliance (QMS & Training)

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

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