Senior Clinical Quality & Compliance Manager

Evolve Scientific; Sydney; On-site; AUD 180,000 - 240,000; Full time

Job summary

Evolve Scientific in Sydney, NSW, is seeking a Senior Clinical Quality & Compliance Manager to lead GCP compliance across regional and global clinical development programs in oncology.

You will provide independent quality oversight, support audits and regulatory inspections, drive CAPA, and collaborate with Clinical Operations, Regulatory Affairs, and study teams to ensure trials meet the highest standards.

Qualifications

• 10+ years in clinical operations, quality, or compliance.
• Strong knowledge of ICH-GCP and global trial regulations.
• Experience with GCP audits, regulatory inspections, CAPA, and quality systems.

Responsibilities

• Provide GCP compliance guidance and quality oversight for assigned studies.
• Support inspection readiness activities, including audit preparation and response management.
• Conduct compliance assessments including remote and site-based reviews.
• Identify, escalate, and manage GCP deviations and quality events.

Skills

ICH-GCP knowledge

GCP audits

Regulatory inspections

CAPA management

Stakeholder management

Quality systems

Job description

Senior Clinical Quality & Compliance Manager (GCP / Inspection Readiness)

• Australia (Sydney preferred)
• Permanent Full-Time

Evolve Scientific is partnering with a leading global oncology organisation to identify an experienced Senior Clinical Quality & Compliance Manager to support regional and global clinical development programs.

This role offers the opportunity to influence clinical quality strategy, strengthen GCP compliance, and support inspection readiness across innovative oncology trials.

The Role

Working within the global clinical compliance function, you will provide independent quality oversight and compliance support across clinical trial activities. You will partner with Clinical Operations, Quality, Regulatory Affairs, and study teams to proactively identify risks, improve processes, and ensure trials are conducted to the highest quality standards.

Key Responsibilities

• Provide GCP compliance guidance and quality oversight across assigned clinical studies.
• Support inspection readiness activities, including audit preparation, inspection hosting, and response management.
• Conduct compliance assessments, including remote and site-based reviews.
• Identify, elevate, and manage GCP deviations, quality events, and compliance risks.
• Support root cause analysis, CAPA development, and effectiveness reviews.
• Analyse compliance trends, quality metrics, and risk indicators to drive improvements.
• Contribute to SOP development, training initiatives, and continuous improvement programs.
• Collaborate with global and regional stakeholders to promote a strong quality culture.

About You

You will be an experienced clinical research professional with:

• 10 years' experience in clinical operations, clinical quality, or clinical compliance.
• Strong knowledge of ICH-GCP and global clinical trial regulations.
• Experience with GCP audits, regulatory inspections, CAPA management, and quality systems.
• Ability to identify risks, influence stakeholders, and drive quality improvements.
• Excellent communication and stakeholder management skills.

Highly regarded: Oncology clinical trial experience and background within pharmaceutical, biotechnology, or CRO environments.

Join a collaborative, science-led organisation committed to delivering innovative cancer therapies worldwide.

Senior Clinical Quality & Compliance Manager Sydney, NSW, AU