Associate Director, Quality Systems and Compliance

About the role

We are looking for an experienced Associate Director to provide strategic oversight and continuous improvement of our Quality Management System (QMS), document control, and training programs. The role is critical to supporting the development and commercialization of innovative gene therapies while ensuring compliance with global regulatory requirements.

Key responsibilities

• Lead the QMS, Document Control, and Training functions across the organization.
• Own and manage the electronic Quality Management System (eQMS), ensuring performance, compliance, and ongoing enhancements.
• Develop, review, approve, implement, and maintain SOPs, work instructions, policies, and quality records.
• Oversee document issuance, revision control, archival, and periodic review processes.
• Manage GxP and non‑GxP training programs, tracking assignment, completion, and effectiveness.
• Create quality metrics and dashboards to monitor system performance and drive improvement.
• Partner with QA, Regulatory Affairs, Manufacturing, Clinical Development, and other functions to ensure system effectiveness.
• Support internal and external audits, regulatory inspections, and supplier audits related to quality systems.
• Lead and mentor the Quality Systems team, fostering a culture of compliance and continuous improvement.

Required profile

• Bachelor’s degree in Life Sciences, Engineering, Quality or related field; advanced degree preferred.
• 10+ years of Quality Assurance experience in biotechnology, pharmaceutical, cell‑therapy or gene‑therapy environments, with progressive leadership responsibility.
• Proven experience managing enterprise‑wide quality systems in a regulated GxP setting.

Required skills

• Advanced proficiency with ZenQMS (administration, configuration, workflow, reporting).
• eQMS administration and continuous improvement.
• SOP development, revision, and lifecycle management.
• Document control and controlled‑document management.
• GxP and non‑GxP training program administration.
• Quality metrics and dashboard creation.
• Regulatory compliance knowledge (FDA, EMA, ICH).