Senior Manager, Development Asset Quality

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

As part of the Development Quality Team, you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for supporting business relationships with defined stakeholder groups in Development, Regulatory and Safety and for the delivery of risk based GCP quality management activities for these stakeholders.

YOU WILL BE RESPONSIBLE FOR:

• Support the execution of the overarching strategy related to proactive and balanced quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) (TAs)
• 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 Clin development and Ops stakeholders and other stakeholders 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 determine robust CAPAs
• Acts as quality approver for Quality Issues and CAPAs as assigned
• Support inspection readiness for assigned programs/portfolio including but not limited to:
• Provide leadership and mentorship to team members in promoting a culture of inspection readiness and balanced clinical compliance
• Provide mentorship to team members in Inspection Readiness and Preparation Activities (e.g., SME training, Mock inspection etc.)
• Support follow up and tracking of inspection dedication and efficiency 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