Senior Manager, Development Asset Quality (DAQ)
Alexion Pharmaceuticals
- Barcelona
- Permanente
- Tiempo completo
- Support the execution of the overarching strategy related to proactive and sustainable 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 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, 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
- Bachelor's degree in life science, or equivalent field, required
- Minimum of 6+ years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and compliance
- Established knowledge of GCP regulations and guidelines (EMA, FDA, PMDA etc.)
- Experience participating in regulatory inspections
- Strong collaborative, influencing and interpersonal skills - curious to understand business environment
- Ability to maintain and create professional networks with stakeholders
- Excellent communication skills; fluent oral and written English
- Advanced degree preferred
- Competencies to be successful for this position include:
- Quality, process, and compliance oriented
- Strong interpersonal skills
- Critical thinking
- Integrity
- Communication
- Teamwork
- Problem solving