Associate Director Development Country Quality
at Alexion PharmaceuticalsInc
Mississauga, ON, Canada -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 03 May, 2025 | Not Specified | 03 Feb, 2025 | 8 year(s) or above | Good communication skills | No | No |
Required Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
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
REQUIREMENT SUMMARY
Min:8.0Max:13.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Life science or equivalent field required
Proficient
1
Mississauga, ON, Canada
