Senior Director, QMS & Regulatory Intelligence

Worldwide Clinical Trials Holdings, Inc.; Australia; Remote; AUD 180,000 - 230,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate Director, Quality Management Systems to provide enterprise leadership for regulatory intelligence, QMS governance, and electronic QMS processes. The role sets strategic direction, governance, and risk oversight across the GxP landscape, translating regulatory change into business priorities and driving large-scale transformation initiatives.

As a senior advisor to Quality Assurance leadership, you will coordinate with cross-functional teams,

Qualifications

• Advanced written and verbal English communication; able to engage senior stakeholders.
• Substantial leadership experience in GxP quality systems and regulatory intelligence.
• Experience supporting regulatory inspections, audits, and inspections readiness.

Responsibilities

• Provide strategic leadership for Regulatory Intelligence Committee and governance.
• Direct enterprise assessment and response for regulatory requirements and QMS changes.
• Oversee development and governance of QMS documentation and eQMS processes.
• Lead cross‑functional governance initiatives to improve transparency and accountability.

Skills

Regulatory intelligence

Quality governance

GxP knowledge

Leadership

Education

Master’s in science/health

Bachelor’s in biology/related

Tools

MS Excel

MS Word

PowerPoint

SharePoint

TrackWise

Job description

Worldwide Clinical Trials is seeking an Associate Director, Quality Management Systems to provide enterprise leadership for regulatory intelligence, QMS governance, and electronic QMS processes. The role sets strategic direction, governance, and risk oversight across the GxP landscape, translating regulatory change into business priorities and driving large-scale transformation initiatives.

As a senior advisor to Quality Assurance leadership, you will coordinate with cross-functional teams,