Senior Manager, Clinical Quality AssuranceSenior Manager / Associate Director, Clinical Quality AssuranceAustralia BasedPermanent Full-TimeLead Quality.
Drive Compliance.
Shape Global Clinical Development.Evolve Scientific is partnering with an innovative, 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 OpportunityAs 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 ResponsibilitiesLead Clinical QA activities across Australian clinical programsProvide expert guidance on GCP, GMP, ICH and regulatory compliance requirementsManage deviations, investigations, CAPAs and quality eventsDrive inspection readiness and compliance monitoring activitiesSupport and maintain Quality Management System documentation,



SOPs and proceduresDevelop risk-based quality management strategies and quality metricsLead vendor qualification, oversight and performance reviewsConduct and manage investigator site and vendor auditsMonitor regulatory developments and implement quality improvements across the businessAbout YouYou'll be a passionate quality leader who thrives in a cooperative and fast-paced environment.Essential requirements:Degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences or related discipline5+ years' experience within clinical research, CRO, biotechnology or pharmaceutical environments3+ years' experience in Clinical Quality Assurance, Quality Compliance or Quality ManagementStrong knowledge of ICH-GCP, TGA regulations and clinical quality systemsExperience managing deviations, investigations, CAPAs and quality oversight activitiesExcellent stakeholder management, communication and influencing skillsFull Australian working rightsHighly regarded:Experience supporting regulatory inspections and responsesInvestigator site and vendor audit experienceExperience within global pharmaceutical or biotechnology organisationsOncology clinical trial experienceAdvanced scientific or healthcare qualificationWhat's On Offer?
Senior leadership opportunity with genuine influence and visibilityExposure to global clinical development programsAbility to shape and strengthen quality systems and processesCollaborative, innovative and high-performing cultureStrong career development and progression opportunitiesOpportunity to contribute to life-changing therapies and meaningful patient outcomesReady to make a global impact through quality leadership?
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📌 Senior Manager, Clinical Quality Assurance (New South Wales)
🏢 Evolve Scientific
📍 New South Wales