Quality Assurance Manager

i-Pharm Consulting; Sydney; On-site; AUD 120,000 - 160,000; Full time

Job summary

i-Pharm Consulting in Sydney seeks an experienced Quality Manager to lead core quality activities in a fast-moving clinical research environment. This hands-on role focuses on participant safety, wellbeing, and practical application of quality and GCP requirements.

The successful candidate will own core quality activities, strengthen the QMS, and work across the organisation to embed a strong and sustainable quality culture.

Qualifications

• Experience in quality assurance within clinical research with strong knowledge of GCP.
• Ability to independently manage SOP development, document control, audits, and CAPAs.
• Strong focus on participant safety, data integrity, and risk-based quality.
• Ability to work autonomously and guide quality improvements.
• Experience leading teams in a growing organisation.

Responsibilities

• Support SOPs, policies, work instructions, templates, and other controlled quality documents.
• Manage document control and keep quality documentation current, compliant, accessible, and fit for purpose.
• Plan, support, and conduct internal, external, vendor, and clinical research audits, including follow-up.
• Oversee quality issues, deviations, non-conformances, investigations, CAPAs, ensuring timely actions.
• Interpret and apply GCP and other clinical requirements, providing practical compliance guidance.
• Support compliance activities with focus on participant safety, rights, wellbeing, and data integrity.
• Contribute to QMS governance with metrics, trend analysis, risk identification, and management reviews.
• Lead continuous improvement initiatives to strengthen systems and reduce quality risk.
• Partner with teams to resolve quality matters and embed shared ownership of outcomes.
• Build external relationships with partners and stakeholders.

Skills

Quality assurance

GCP knowledge

QMS management

Audits

CAPA handling

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.

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.

About the Role

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.

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.

Qualifications

• 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.