Overview

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 the 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 frontline 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.

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...