Director, Operational Quality — Remote in Australia

Avance-Clinical; Australia; Remote; AUD 180,000 - 250,000; Full time

Benefits offered by this job

Competitive salary

Flexible work arrangements

Industry-leading technology and tools

Diverse, challenging projects

Career progression opportunities

Supportive leadership and culture

Stability with a growing CRO

Job summary

Avance Clinical is recruiting a Director, Operational Quality to design, implement and continuously enhance a global Quality Framework across Operations. The role reports to the EVP, Global Operations and is based in Australia with remote work flexibility.

The ideal candidate has 15+ years in biotech/pharma/CRO, with strong ICH GCP knowledge and experience in leading global clinical trial delivery, governance, and quality metrics.

Qualifications

• 15+ years in biotech/pharma/CRO with GCP exposure.
• Experience in project management and clinical operations; biometrics beneficial.
• Proven track record in operational quality, quality systems, risk-based quality management.
• Strong knowledge of ICH GCP guidelines and regulatory expectations.
• Experience leading global clinical trial delivery and engaging client expectations.
• Ability to define quality metrics, KRIs, dashboards, and drive accountability.
• Strategic thinking, team leadership, and cross-cultural collaboration.
• Strong client-facing communication; governance participation and sponsor escalations.

Responsibilities

• Design, implement, and continuously improve a global Quality Framework across Operations.
• Provide senior leadership and governance to ensure quality in Study Start-Up, Biometrics, Clinical Operations, Site Solutions, Safety and Medical Writing.
• Establish governance structures, quality metrics, escalation pathways and cross-functional oversight.
• Partner with functional leaders to make operational quality a differentiator in client communications and governance discussions.

Skills

Quality systems

Risk-based management

Operational governance

ICH GCP knowledge

Global clinical trial delivery

Strategic thinking

Team management

Client-facing communication

Problem solving

Confidentiality & privacy

Education

Bachelor’s degree in life sciences, pharmacy, nursing or related discipline

Job description

Avance Clinical is recruiting a Director, Operational Quality to design, implement and continuously enhance a global Quality Framework across Operations. The role reports to the EVP, Global Operations and is based in Australia with remote work flexibility.

The ideal candidate has 15+ years in biotech/pharma/CRO, with strong ICH GCP knowledge and experience in leading global clinical trial delivery, governance, and quality metrics.