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 cutting-edge, globally recognised biopharmaceutical organisation to appoint aSenior 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 seasonedClinical QA professionallooking 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 s

📌 Senior Manager, Clinical Quality Assurance (City of Sydney)
🏢 Evolve Scientific
📍 City of Sydney