Professional Quality Assurance Specialist
3 days ago
Job Description:
We are seeking a dedicated Quality Assurance Professional to accelerate customer success by translating unique clinical, medical affairs, and commercial insights into outcomes. As part of our Clinical Development model, you will be at the forefront of enhancing quality in project delivery.
Our ideal candidate will lead and facilitate local activities to identify, analyze, and rectify systemic quality issues in clinical delivery. You will provide guidance and hands-on support to project teams for CAPA development and tracking, monitoring available KPI/Metrics reports across Business Units to identify common tendencies/issues for quality improvement.
Responsibilities:
- Lead and facilitate local activities to enhance quality in project delivery.
- Work across all Business Units to identify, analyze, and rectify systemic quality issues in clinical delivery that are country-specific in origin.
- Provide guidance and hands-on support to project teams for CAPA development and tracking.
- Monitor available KPI/Metrics reports across the Business Units and identify common tendencies/issues for quality improvement at a local level.
- Support project teams in communicating and managing complex quality issues with the sponsor and/or sites. Mentor junior staff members as needed.
- Engage in identifying country-specific training needs across the Business Units and work with global and local stakeholders to provide required solutions.
- Collaborate with global stakeholders in quality-related initiatives and activities to enhance quality in project delivery at a local level while maintaining compliance with global processes.
- Design and initiate audit/inspection-readiness assessments and improvement plans across all projects. Collaborate with global/regional process owners to implement enduring solutions (into training, SOPs/WIs, clinical processes, Trusted Process, etc.) to ensure continuous audit/inspection readiness.
- Work with regional Process Quality Management leads to engage in quality enhancement at a local level.
Qualifications:
- Bachelor's degree in science or healthcare, or equivalent combined education and experience.
- Moderate clinical research experience in Pharma/CRO/Site Management preferred.
- Knowledge of ICH GCP, JGCP, or In-country equivalent required.
- Basic knowledge of project management required.
- Experience in project management in clinical operations preferred.
- Extensive leadership skills preferred. Ability to act independently and proactively on personnel management, customer management, and project management.
- Ability to perform multiple tasks simultaneously to meet aggressive deadlines.
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