Director, Development Asset Quality Strategy
hace 3 días
Job Summary
Dmar General Contracting & Development Inc. is seeking a highly skilled and experienced Quality Director, Clinical Development to join our team. As a key member of our Development Quality Team, you will be responsible for driving Quality Culture with Development, Regulatory, and Safety stakeholders.
Key Responsibilities
- Manage business relationships with defined clinical development stakeholder groups and senior leaders in Development, Regulatory, and Safety.
- Develop and execute a GCP risk-based robust quality management strategy for assigned areas.
- Represent DQA on Alexion Global Program Teams (GPTs) and Regulatory Strategy Teams (RSTs) to identify critical to quality risks and mitigation strategies.
- Proactively identify Key Quality and Risk Indicators (KQIs/KRIs) for assigned areas and develop mechanisms for detection, oversight, and trending.
- Work with Development Quality peers to ensure escalation of risks and issues identified at a study level to relevant stakeholders.
- Provide guidance to junior team members for global/systemic clinical quality issue investigations.
- Mentor new and existing employees as per established on-boarding plan and focus improvement areas.
- Work with cross-functional and other quality partners to proactively identify areas of risk, improvement, or KPI/KQIs.
- Serve as the quality expert for global/systemic clinical quality issue investigations, including leading Quality Event reportability assessments, investigations, and Root Cause Analysis.
Requirements
- Strong leadership and communication skills.
- Experience in clinical development and quality management.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
- Strong analytical and problem-solving skills.
- Ability to mentor and develop junior team members.
Language
English (en-US)
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