Quality Manager

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

A growing clinical research organisation is seeking an experienced Quality Manager who can step into a fast-moving environment and add value from day one. This is a hands-on senior quality role for someone who is passionate about clinical research, participant safety and wellbeing, and the practical application of quality and GCP requirements. The successful candidate will take ownership of core clinical quality activities, strengthen the Quality Management System (QMS), and work collaboratively across the organisation to embed a strong and sustainable quality culture.

Key responsibilities

Support the development, review, approval, implementation, and ongoing maintenance of SOPs, policies, work instructions, templates, and other controlled quality documents.

Manage document control activities and help ensure quality documentation remains current, compliant, accessible, and fit for purpose.

Plan, support, and conduct internal, external, vendor, and clinical research audits, including audit preparation, reporting, follow-up, and closure of findings.

Oversee quality issues, deviations, non-conformances, investigations, root cause analysis, and corrective and preventive actions (CAPAs), ensuring actions are proportionate, effective, and completed on time.

Interpret and apply Good Clinical Practice (GCP) and other relevant clinical research requirements, providing practical compliance guidance to stakeholders.

Support clinical research compliance activities with a clear focus on participant safety, rights, wellbeing, and data integrity.

Contribute to the implementation, optimisation, and ongoing governance of the QMS, including quality metrics, trend analysis, risk identification, and management review inputs.

Lead continuous improvement initiatives that strengthen systems, reduce quality risk, and improve operational consistency as the organisation grows.

Partner with teams across the organisation to resolve quality matters, improve ways of working, and build shared ownership of quality outcomes.

Build trusted and collaborative relationships with external partners, service providers, clinical research stakeholders, and other relevant parties.

About you

Demonstrated quality assurance or quality management experience within clinical research, with strong practical knowledge of GCP and clinical research quality systems.

Proven ability to independently manage SOP development, document control, audits, quality issues, CAPAs, clinical compliance activities, and QMS improvement.

A strong understanding of participant safety and wellbeing, data integrity, and risk-based quality principles within a clinical research setting.

The technical confidence and judgement to contribute quickly, work autonomously, and operate with minimal onboarding from a quality perspective.

Experience working in a growing, changing, or evolving organisation, with the flexibility to balance strategic priorities and hands‑on delivery.

Excellent communication, stakeholder management, collaboration, and influencing skills, with the ability to build strong internal relationships at all organisational levels.

Strong external relationship skills and the ability to establish trusted partnerships with a broad range of clinical research stakeholders.

People leadership, coaching, or mentoring capability, with the potential to support and develop junior quality staff as the team grows.

A practical, solutions-focused mindset and a genuine commitment to strengthening quality culture and continuous improvement.