Head of Quality Management Systems & Regulatory Intelligence

Worldwide; Sydney; Hybrid; AUD 180,000 - 240,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate Director of Quality Management Systems in Sydney, Australia. The role leads enterprise governance for regulatory intelligence and eQMS, driving strategic oversight and risk-based management across the organisation.

You will translate regulatory change into business priorities, sponsor complex transformation programmes, and ensure inspection-ready quality systems across global studies.

Qualifications

• Advanced written and verbal English communication skills.
• Ability to engage effectively with senior and external stakeholders.
• Strong leadership and people-management capabilities.
• Deep knowledge of GxP quality systems and regulatory expectations.

Responsibilities

• Lead Regulatory Intelligence and QMS governance initiatives across global functions.
• Co-chair the QMS governance committee and drive risk-based oversight.
• Oversee QMS document governance, change control, and eQMS implementation.
• Direct horizon scanning of regulatory requirements and translate into strategic actions.
• Ensure inspection readiness and support regulatory inspections and audits.

Job description

Worldwide Clinical Trials is seeking an Associate Director of Quality Management Systems in Sydney, Australia. The role leads enterprise governance for regulatory intelligence and eQMS, driving strategic oversight and risk-based management across the organisation.

You will translate regulatory change into business priorities, sponsor complex transformation programmes, and ensure inspection-ready quality systems across global studies.