Associate Director Development Country Quality
at
Alexion PharmaceuticalsInc
Mississauga, ON, Canada
-
Full Time
Start Date
Immediate
Expiry Date
05 May, 25
Salary
0.0
Posted On
05 Feb, 25
Experience
8 year(s) or above
Remote Job
No
Telecommute
No
Sponsor Visa
No
Skills
Good communication skills
Industry
Pharmaceuticals
Description
Responsibilities
Assisting in the development of an overarching strategy related to proactive and sustainable quality and compliance for all programs and/or countries assigned. Responsible to drive a culture of data and risk driven quality of clinical trials.
Work with cross functional and other 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
Serve as the quality expert for country 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
Be accountable for leading inspection readiness (local) for assigned programs/portfolio/countries including but not limited to:
Provide leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical compliance
Provide guidance to team members in Inspection Readiness and Preparation Activities (e.g., SME training.)
Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/countries
Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements
Drive continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues
Actively participate in meetings driving quality and business performance
Support Due Diligence and integration activities as assigned
Linked-in
Google