Clinical Supplies Quality Lead
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.
As a Clinical Supplies Quality Lead, you will play a key part in developing and maintaining high-performance teams/organisations, influencing/motivating global teams to achieve results—delivering on business and program goals. 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 demonstrated strong leadership skills, with experience as a Responsible Person on a WDA preferred.