Process Validation Manager

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions: Office Job Description: The network of drug substance manufacturing sites includes St. Louis, USA, Lengnau, Switzerland, Groningen, Netherlands and Brisbane, Australia. The success of the network relies on each site to introduce and validate commercial processes, remaining compliant with international quality requirements as defined by TGA, FDA, EMA and other regulatory agencies as applicable. You will lead Process Validation (PV), Cleaning Validation and Continued Process Verification (CPV) efforts for the Brisbane site utilising the lifecycle approach, in accordance with the Site Validation Master plan, client-specific Validation Plans and within the Quality System. As Manager, Process Validation, you will uphold Customer Allegiance (CAS), quality of work (Right-First-Time - RFT) and On-Time Delivery (OTD) for Validation activities while ensuring product quality, robust processes and regulatory compliance. You will train and mentor staff and contribute to the global Process Validation network, supporting and driving harmonisation. You will be seen as the Process Validation point of contact for the site, speaking with auth...