Compliance Lead (Clinical Quality)

You’ll work independently from study delivery teams to provide critical oversight and expert guidance, ensuring studies are conducted to the highest regulatory and ethical standards.
Operating within a regional model, you’ll collaborate with peers across APAC while supporting globally aligned clinical programs.

Key Responsibilities

• Provide expert GCP compliance guidance to clinical study teams
• Lead and support inspection readiness, audits and regulatory interactions
• Identify, investigate and escalate compliance risks and quality issues
• Drive corrective and preventative actions (CAPA) and continuous improvement initiatives
• Conduct site compliance reviews (remote and on-site) to assess study conduct and quality
• Analyse trends and data to identify systemic risks across studies and regions
• Partner cross-functionally to embed best practice and strengthen quality frameworks

What We’re Looking For

• Extensive experience in clinical quality / GCP compliance within pharma or CRO
• Strong background in audits, inspections and regulatory readiness
• Deep understanding of clinical trial conduct and ICH-GCP requirements [GCO JAPAC...Compliance | Word]
• Ability to operate independently in a regional, matrix environment
• Strong analytical, problem-solving and communication skills 

✔️ Senior-level experience preferred
✔️ Regional exposure advantageous
✔️ We may also consider high-potential candidates stepping up

Working Model & Travel

• Flexible, remote-friendly environment
• ~25% travel, primarily within Australia/NZ [GCO JAPAC...Compliance | Word]
• Regional scope with local support in key markets

Why This Role?

• Join a growing clinical quality function with increasing study activity
• Work in a highly respected, niche discipline where your expertise is valued
• Gain regional exposure without heavy travel burden
• Collaborate with a supportive and experienced leadership team
• Competitive salary + bonus + additional benefits

The Market Reality These roles are rare and highly sought after — we’re specifically looking for professionals who bring true quality leadership (not just clinical operations experience).

If you’re passionate about driving standards, influencing quality culture and shaping clinical compliance across regions, we’d love to speak with you.