Senior Manager, Clinical Quality Assurance

Senior Manager / Associate Director, Clinical Quality Assurance

• Australia Based
• Permanent Full-Time

Lead Quality. Drive Compliance. Shape Global Clinical Development.

Evolve Scientific is partnering with an innovative, globally recognised biopharmaceutical organisation to appoint a Senior Manager or Associate Director, Clinical Quality Assurance. This is a rare opportunity to take ownership of Quality Assurance activities across Australian clinical development programs while contributing to cutting-edge therapies that have the potential to transform patient outcomes.

If you're a seasoned Clinical QA professional looking to step into a highly visible leadership role with global exposure, this could be your next career-defining move.

The Opportunity

As the local Clinical Quality Assurance lead, you'll be responsible for driving quality strategy, ensuring GxP compliance, supporting audit and inspection readiness, and partnering closely with Clinical Operations and key stakeholders to embed a culture of quality across clinical programs.
You'll have the opportunity to influence quality systems, vendor oversight, risk management and continuous improvement initiatives within a fast-growing, science-driven organisation.

Key Responsibilities

• Lead Clinical QA activities across Australian clinical programs
• Provide expert guidance on GCP, GMP, ICH and regulatory compliance requirements
• Manage deviations, investigations, CAPAs and quality events
• Drive inspection readiness and compliance monitoring activities
• Support and maintain Quality Management System documentation, SOPs and procedures
• Develop risk-based quality management strategies and quality metrics
• Lead vendor qualification, oversight and performance reviews
• Conduct and manage investigator site and vendor audits
• Monitor regulatory developments and implement quality improvements across the business

About You

You'll be a passionate quality leader who thrives in a collaborative and fast-paced environment.

Essential requirements:

• Degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences or related discipline
• 5+ years' experience within clinical research, CRO, biotechnology or pharmaceutical environments
• 3+ years' experience in Clinical Quality Assurance, Quality Compliance or Quality Management
• Strong knowledge of ICH-GCP, TGA regulations and clinical quality systems
• Experience managing deviations, investigations, CAPAs and quality oversight activities
• Excellent stakeholder management, communication and influencing skills
• Full Australian working rights

Highly regarded:

• Experience supporting regulatory inspections and responses
• Investigator site and vendor audit experience
• Experience within global pharmaceutical or biotechnology organisations
• Oncology clinical trial experience
• Advanced scientific or healthcare qualification

What's On Offer?

• Senior leadership opportunity with genuine influence and visibility
• Exposure to global clinical development programs
• Ability to shape and strengthen quality systems and processes
• Collaborative, innovative and high-performing culture
• Strong career development and progression opportunities
• Opportunity to contribute to life-changing therapies and meaningful patient outcomes

Ready to make a global impact through quality leadership?

Apply now or contact Nick Shearing in the Evolve Scientific Sydney Office for a confidential discussion.


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