Clinical Quality Director

About the CompanyWe 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.About the RoleWe 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.ResponsibilitiesLead 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 operationsDevelop and implement vendor management strategies, including:Lead and conduct on-site study site audits, including:Development/maintenance of audit tools, checklists, and audit plansAuthoring and/or reviewing audit reports and audit documentationTimely 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. QualificationsBachelor’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 trialsRegulatory authority inspection experience (preferred).Strong written and verbal communication skills.Full working rights in Australia required. Required SkillsStrong 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 bwalsh@i-pharmconsulting.com