Senior Manager, Development Asset Quality

at  Alexion PharmaceuticalsInc

Location: Mississauga, Canada
Job reference: R-197780
Date posted: 04/19/2024
Location: Mississauga
As part of the Development Quality Team, you will drive Quality Culture with Development, Regulatory and Safety collaborators, through learning, embedding a quality attitude, and completing continuous improvement opportunities, supporting business relationships with defined collaborator groups and for the delivery of risk based GCP quality management activities for these collaborators.

• Support the execution of the overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Areas.
• Support quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develops mechanisms of KQI/KRI, detection, oversight and trending with Clinical development and Ops collaborators and other partners and functions such as Risk based Quality Management
• Support global/systemic clinical quality issue investigations, which includes:
• In collaboration with issue owners lead Quality Event reportability assessments, investigations and Root Cause Analysis
• Perform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to resolve robust CAPAs
• Acts as quality approver for Quality Issues and CAPAs as assigned
• Support inspection readiness for programs/portfolio:
• Provide guidance to team members in Inspection Readiness and Preparation Activities (e.g., SME training, Mock inspection etc.)
• Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/Therapeutic Area
• Support continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues
• Support in meetings driving quality and business performance