Lead Clinical Operations & Governance at CARED, a health - tech revolutionising allied health. Shape the future of care in Australia and beyond.
About the role
- GCP Compliance Manager overseeing compliance and quality in global clinical operations at Novartis. Responsible for audits, inspections, and quality management supporting clinical research excellence.
Responsibilities
- Accountability for the GCP compliance oversight and control of regulated GCO activities focusing on GCO wide activities potentially having a high impact on GCO ability to deliver as per objectives, as per assignment.
- Provide GxP expertise and may be referred in providing GCP Compliance support to other functions, compliance, process, training and risk groups.
- Management of the GCO GCP audits and GCP inspections landscape and coordination of system/process audits & global inspections supporting authorizations including inspection readiness.
- Manage GCO wide systemic quality issues, deviations and quality events as per assignment, providing expertise in investigation, Root Cause Analysis (RCA) and Corrective And Preventive Action (CAPA) development.
- Involve and collaborate as needed with the relevant functions across GCO, GDD and the wider organization, such as Quality Assurance.
- Contribute to the maintenance of a centralized knowledge of audits/inspections related outcomes working closely with Training overseeing GCO Knowledge Management.
Requirements
- 8+ years industry experience specifically in clinical operations with an advanced knowledge of clinical research international standards and regulatory requirements from Health Authorities.
- Audits and inspections experience highly desirable.
- Organizational and analytical skills associated with an aptitude in quality management and continuous improvement.
- Critical thinking ability and risk management and risk based knowledge and mindset.
- Strong skills to facilitate/optimize contribution of team members as individuals and members of a cohesive team.
- Strong capacity for working independently with minimal guidance.
- Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills.
Benefits
- Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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