Senior Quality Associate

Job description

Position Purpose The Senior Quality Associate is responsible for managing deviations, investigations, CAPAs, product technical complaints and change controls associated with development activities and manufacture of Investigational Medicinal Product within CSL Clinical Development portfolio. To do this, the GMP Site Quality Associate has the primary purpose of ensuring compliance with GMP/GSP/GxP by providing front‑line quality guidance and support across all phases of Technical Product Development. You will also ensure self‑inspections are conducted and followed up in a timely manner and provide quality and compliance support throughout all aspects of technical product. Main Responsibilities and Accountabilities: - Participate in IPT Project and associate delivery team meetings, providing quality/compliance leadership, guidance and advice - Manage deviations and OOS investigations and facilitate/attend Deviation Review Board meetings as required - Manage and facilitate the deviation meeting process, manage deviations to closure, including significant and complex deviations, to ensure that information recorded is comprehensive and remedial actions are appropriate and executed in a...