Supply Chain Quality Expert
We are seeking a highly experienced Supply Chain Quality Expert to join our team. In this role, you will be responsible for ensuring the high-quality standards of our clinical supplies are met. This includes certification and batch release of clinical supplies, acting as a Responsible Person on a WDA for Pre-Approval Access, supporting Health Authority GMP/GDP inspections and audits across the supply chain, advising stakeholders on quality issue management and process enhancement/compliance, incorporating global regulatory trends and changes into Supply Chain Quality, manufacturers authorisation update and maintenance, and rapid communication of quality issues or significant deviations to business partners and senior management.
A strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance is essential. You must also have proven track record of building/maintaining high-performance teams/organisations and influencing/motivating global teams to achieve results—delivering on business and program goals.