Job Description
We strive to create a collaborative, energized work environment focused on growth and opportunity. We value diversity, innovation, and a strong commitment to excellence and to the patients we serve.
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About the Role
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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.
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Responsibilities
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Lead and execute overall Quality Assurance strategy supporting clinical development in the Australian office.
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Partner with Clinical Operations and cross-functional stakeholders to deliver QA oversight, including:
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Review, comment on, and support revisions of SOPs, Work Instructions (WIs), and other quality management documentation with global stakeholders.
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Provide SOP clarification and GxP guidance (including GCP and GMP) to support clinical development locally.
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Develop and implement risk management strategies for clinical operations
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Develop and implement vendor management strategies, including:
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Lead and conduct on-site study site audits, including:
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Development/maintenance
of audit tools, checklists, and audit plans
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Authoring and/or reviewing audit reports and audit documentation
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Timely
escalation/communication
of quality or compliance issues (critical findings, potential misconduct, significant deviations)
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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.
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Qualifications
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Bachelor's degree or higher in a scientific or healthcare discipline (preferred).
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5+ years progressive experience in clinical research or clinical operations within biotech/pharma and/or CRO environments.
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5+ years experience in Quality Assurance / Quality Compliance.
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Solid understanding of QA methodologies and compliance approaches in clinical development.
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GCP requirements for clinical trials
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Regulatory authority inspection experience (preferred).
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Strong written and verbal communication skills.
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Full working rights in Australia required.
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Required Skills
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Strong understanding of QA methodologies and compliance approaches in clinical development.
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Demonstrated knowledge and practical application of TGA regulations, ICH guidelines, and GCP requirements for clinical trials.
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Strong written and verbal communication skills.
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📌 Clinical Quality Director (New South Wales)
🏢 i-Pharm Consulting
📍 New South Wales