Senior Technical Manager
Current• Provided consistent support to Facilities and Engineering during Quality Management System transition, including comprehensive review of new work orders for potential Unplanned Events and revisions to the relevant guidance documents to capture clear event response processes to reduce overall UPEs• Facilitated the transition of intake and triage responsibilities of new discrepant events to the frontline quality support team• Developed work instructions for the triage and intake of new Unplanned Events• Continually improve the discrepancy management process, including the creation of visual management to explain process flows, numerous job aids that are used throughout the assessment process, and a tool to track the progress of discrepant events across various lifecycle milestones• Functioned as mentor and first point of contact for MQA Associates on rotation into the Quality Reviewer group, providing support and coaching, especially with soft skills and conflict resolution• Train, coach, and develop a variety Discrepancy Owner groups, including those from operations, automation, maintenance, and process engineering• Completed the Roche Investigator Certification Program and led an Investigation into a repeat CQA excursions during buffer formulation• Assess, and when necessary, escalate discrepant events to quality management and through the Quality Review Board, requiring clear and concise summaries of complex events• Assumed QRB escalation and presentation responsibilities for an identified trend of capping discrepancies, providing a clear picture of the background and timeline of events, actions taken, outcomes, and next steps• Implemented LPS to Area 3 GPMF Manufacturing, which functioned a lighthouse for the network and involved roadshows with numerous Genentech and Roche leaders
