Leading and conducting comprehensive audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and guidelines.
Collaborating with cross-functional teams to identify areas for improvement in quality assurance processes and practices.
Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.
Providing expert guidance and recommendations to stakeholders on quality assurance best practices and regulatory requirements.
Contributing to the continuous improvement of quality assurance programs and initiatives.
Quality Event Assessment and Investigation.
Notification to Management.
Root Cause Analysis / Gap Analysis / Due Diligence.
Process Analysis and Improvement.
CAPA Plan Development and Management.
Risk Mitigation Tracking.

7+ years’ experience or equivalent with BS or 6+ years’ experience or equivalent with MBA/MS
Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory
Regulatory inspection experience
Process and system management experience
Detailed knowledge of clinical trial processes and relationships required
Knowledge of GCP requirements and applicable SOPs and regulations
Project management, administrative, and technical capabilities are required
Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred.

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Principal Auditor – Quality Assurance

Key skills