About the Company

We strive to create a collaborative, energized work environment focused on growth and prospect. We value diversity, innovation, and a strong commitment to excellence and to the patients we serve.

About the Role

We are seeking a Clinical Quality Manager to head up and execute quality assurance strategy and compliance activities to support clinical development activities in Australia. This position is open to Senior Manager / Associate Director levels depending on the candidate’s depth of knowledge, skills, and relevant experience.

Responsibilities

- Lead and execute overall Quality Assurance strategy supporting clinical development in the Australian office.
- Partner with Clinical Operations and cross-functional stakeholders to deliver QA oversight, including:
- Review, comment on, and support revisions of SOPs, Work Instructions (WIs), and other quality management documentation with global stakeholders.
- Provide SOP clarification and GxP guidance (including GCP and GMP) to support clinical development locally.
- Develop and implement risk management strategies for clinical operations
- Develop and implement vendor management strategies, including:
- Lead and conduct on-site study site audits, including:
- Development/maintenance of audit tools, checklists, and audit plans
- Authoring and/or reviewing audit reports and audit documentation




- Timely escalation/communication of quality or compliance issues (critical findings, potential misconduct, significant deviations)
- Proactively monitor emerging regulatory requirements, guidance, and industry standards and ensure changes are communicated and embedded into policies, procedures, and business processes to maintain compliance.

Qualifications

- Bachelor’s degree or higher in a scientific or healthcare discipline (preferred).
- 5+ years progressive experience in clinical research or clinical operations within biotech/pharma and/or CRO environments.
- 5+ years experience in Quality Assurance / Quality Compliance.
- Strong understanding of QA methodologies and compliance approaches in clinical development.
- GCP requirements for clinical trials
- Regulatory authority inspection experience (preferred).
- Robust written and verbal communication skills.
- Full working rights in Australia required.

Required Skills

- Strong understanding of QA methodologies and compliance approaches in clinical development.
- Demonstrated knowledge and practical application of TGA regulations, ICH guidelines, and GCP requirements for clinical trials.
- Strong written and verbal communication skills.

If you are interested in finding out more please reach out to Brian at [email protected]

📌 Clinical Quality Director (Sydney)
🏢 i-Pharm Consulting
📍 Sydney