Senior Quality Manager – Clinical Research & QMS Lead

i-Pharm Consulting; Sydney; On-site; AUD 140,000 - 170,000; Full time

Job summary

i-Pharm Consulting seeks an experienced Quality Manager to lead hands-on quality activities in a fast-moving clinical research environment in Sydney. You will own core quality processes, strengthen the QMS, and promote a culture of compliance and participant safety.

The role requires practical GCP knowledge, audit management, CAPAs, SOP development, and collaboration across teams to embed quality into daily operations as the company scales.

Qualifications

• Experience in quality assurance within clinical research.
• Strong knowledge of GCP and quality systems.
• Experience managing SOP development and document control.
• Ability to lead CAPAs and audits with risk-based thinking.

Responsibilities

• Support development and maintenance of SOPs, policies, work instructions, templates and other quality documents.
• Lead document control to ensure current, compliant quality records.
• Plan and conduct internal, external, vendor and clinical research audits; report and close findings.
• Oversee deviations, non-conformances, investigations, CAPAs; ensure timely closure.
• Apply GCP and other clinical requirements; provide practical compliance guidance.
• Support participant safety, rights, wellbeing, and data integrity in compliance activities.
• Contribute to QMS governance, metrics, trend analysis, and management reviews.
• Lead continuous improvement initiatives to strengthen systems and reduce risk.
• Collaborate with teams to resolve quality issues and embed shared ownership of quality.

Skills

GCP knowledge

Quality assurance

Audit management

CAPA

SOP development

QMS improvement

Document control

Stakeholder management

Leadership

Job description

i-Pharm Consulting seeks an experienced Quality Manager to lead hands-on quality activities in a fast-moving clinical research environment in Sydney. You will own core quality processes, strengthen the QMS, and promote a culture of compliance and participant safety.

The role requires practical GCP knowledge, audit management, CAPAs, SOP development, and collaboration across teams to embed quality into daily operations as the company scales.