Director, Operational Quality

Director, Operational Quality

• Based in Australia – remote
• Join Frost & Sullivan's 2026 Global Company of the Year for Biotech CRO Leadership
• Reporting to: EVP, Global Operations     

At Avance Clinical, we're helping innovative biotech and pharmaceutical companies bring life-changing therapies to patients faster. Following significant growth and new global project wins, we're expanding our team and looking for a Director, Operational Quality to join us in this newly created, Australian based, global role.

Why Join Avance Clinical?

Global Recognition: Work for the CRO recognised by Frost & Sullivan as the 2026 Global Company of the Year for excellence in biotech CRO leadership.
Work Anywhere in Australia: Enjoy genuine flexibility and autonomy with a fully remote role supported by industry-leading technology and a highly collaborative culture.
Accelerate Your Career: Join one of Australia's fastest-growing CROs, where high performers are recognised and supported to advance their careers.
Meaningful, Diverse Projects: Work with emerging biotech companies developing the next generation of therapies.
 
The Opportunity

The Director, Operational Quality is responsible for designing, implementing and continuously improving a global Quality Framework across Operations to support scalable, high-quality service delivery.

Providing senior leadership, supporting Project Management, Study Start-Up, Biometrics, Clinical Operations, Site Solutions, Safety, Medical Monitoring and Medical Writing, ensuring that operational quality is visible, measurable and owned by the business. The role is accountable for establishing practical governance, meaningful quality metrics, principles-based escalation pathways and cross-functional oversight that enable earlier identification of risks, stronger intervention on at-risk projects and more consistent delivery outcomes.

This role works alongside functional leaders as a quality partner and operates as a peer to Quality Assurance in areas of shared ownership, while supporting Avance’s strategic goal of making operational quality a visible differentiator in commercial activities, governance discussions and client communications.
  
  
What We're Looking For

• Bachelor’s degree in life sciences, pharmacy, nursing or other relevant discipline, or equivalent industry experience.
• Industry experience in appropriate positions that complement the requirements of this position (a minimum of 15 years’ experience in the biotech/pharma/CRO industry working in a GCP environment across complex clinical trial delivery). Previous working experience in Project Management and Clinical Operations is essential, while experience in Biometrics is favourable.
• Demonstrated experience in operational quality, quality systems, risk-based quality management, operational governance, or a closely related leadership capability within clinical research.
• Strong working knowledge of ICH GCP guidelines, applicable regulatory requirements and the practical quality expectations associated with clinical trial delivery.
• Experience supporting or leading global clinical trial delivery and understanding of the increased quality, governance and client expectations.
• Demonstrated ability to define and use quality metrics, KRIs, dashboards or other management information to identify trends, support decisions and drive accountability.
• Proficiency in strategic thinking, effective team management, and fostering cross-cultural collaboration to drive the execution of growth initiatives globally.
• Strong client-facing communication skills, including the ability to participate in governance meetings, support sponsor escalations and contribute to business development discussions where required.
• Capacity to innovate, solve complex problems, and adapt to changing market dynamics while ensuring regulatory compliance and leveraging technology for sustainable growth.
• Demonstrated ability to take initiative, working autonomously to manage issue escalation and engage in creative problem-solving, while exercising good judgment.
• Clear understanding of confidentiality, privacy, and quality obligations in the clinical trial environment.
• Ability and willingness to travel. Minimal level of travel may be required (up to 25%).

 
What You'll Receive

• Competitive salary package
• Flexible work arrangements
• Industry-leading technology and systems
• Diverse, intellectually stimulating projects
• Clear career progression opportunities
• Supportive leadership team and collaborative culture
• Long-term stability with a growing global CRO

About Avance Clinical

Avance Clinical is a leading Australian CRO providing specialised drug development services to the biotechnology and pharmaceutical industries. With origins dating back to the 1980s, we have built an outstanding reputation for quality, service excellence and innovation. Today, we partner with biotech companies globally to accelerate the development of new medicines.

Apply Now
If you're looking for an opportunity to lead impactful clinical trials while enjoying genuine flexibility and career progression, we'd love to hear from you.

  
  
Quality / compliance / clinical trials / biotech / biometrics / CRO / pharmaceutical / clinical research / Australia