Associate Director, Regulatory QMS & Strategy

Worldwide Clinical Trials; Sydney; Presencial; AUD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking an Associate Director, Quality Management Systems to provide enterprise leadership for regulatory intelligence, QMS governance, and eQMS processes. You will translate regulatory changes into business priorities, sponsor complex transformations, and ensure inspection readiness across GxP operations.

You will lead cross-functional governance, drive risk-based oversight, and collaborate with Quality Assurance leadership to shape strategy and operating models.

Formación

• Advanced written and verbal English communication skills for senior and external stakeholders.
• Substantial leadership experience in GxP quality systems, regulatory intelligence, or related disciplines.
• Experience supporting regulatory inspections, audits, and readiness activities.
• Deep knowledge of ICH, FDA, EMA, MHRA and global GxP requirements.

Responsabilidades

• Lead the Regulatory Intelligence Committee (RIC) governance and oversight.
• Advise Senior Quality Review forum and leadership on regulatory developments and enterprise risks.
• Direct horizon scanning of the global regulatory landscape and integration into business priorities.
• Oversee QMS and eQMS governance, documentation, and change management.
• Co-chair the QMD Governance Committee and set strategic agenda.
• Provide strategic QMS expertise to audit and inspection programs and drive continuous improvement.

Conocimientos

Regulatory intelligence

Quality management systems

QMS governance

Cross-functional leadership

Stakeholder engagement

Risk-based oversight

Educación

Master’s degree in a scientific or allied health field

Bachelor’s degree in a biological, physical, health, pharmacy or related field

Herramientas

TrackWise

eQMS

Microsoft Office (Excel, Word, PowerPoint, SharePoint)

Descripción del empleo

Worldwide Clinical Trials is seeking an Associate Director, Quality Management Systems to provide enterprise leadership for regulatory intelligence, QMS governance, and eQMS processes. You will translate regulatory changes into business priorities, sponsor complex transformations, and ensure inspection readiness across GxP operations.

You will lead cross-functional governance, drive risk-based oversight, and collaborate with Quality Assurance leadership to shape strategy and operating models.