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.
- 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?
Senior Manager, Clinical Quality Assurance employer: Evolve Scientific an NES Fircroft Company
Join a dynamic and supportive team at our brand-new clinical research site in Penrith, where you will have the unique opportunity to shape operations and enhance participant experiences from the ground up. We offer flexible working arrangements to promote work-life balance, alongside strong professional development and career progression opportunities in a collaborative environment focused on innovative clinical trials. This is an ideal role for those passionate about making a meaningful impact in healthcare while enjoying a stable and rewarding career path.
Contact Details:
Evolve Scientific an NES Fircroft Company Recruitment Team
