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Quality Lead Gcp
vor 3 Wochen
**Quality Lead GCP**:
**Location**
- Geneva, Switzerland
**Business Sector**
- Biotechnology
**Job ref**
- 22192
**Published**
- 12 days ago
Our client, a leading biopharmaceutical company, operating at the forefront of cutting-edge scientific research and drug development, is seeking a Quality Lead GCP to play a pivotal role in ensuring the quality and compliance of their clinical development processes.
**Key Responsibilities**:
- **Quality Assurance**: Oversee and manage the quality assurance processes related to clinical development activities, including clinical trials, to ensure compliance with regulatory standards, SOPs, and guidelines.
- **Risk Management**: Implement and maintain risk management strategies to identify and mitigate quality and compliance risks throughout the clinical development process.
- **Audit and Inspection Readiness**: Prepare and lead the organization for audits and inspections, collaborating with cross-functional teams to ensure successful outcomes.
- **Training and Development**: Provide guidance and training to clinical teams on quality-related matters, fostering a culture of quality and continuous improvement.
- **Quality Metrics**: Establish, monitor, and report on key quality metrics to drive process improvements and maintain the highest quality standards.
- **Regulatory Compliance**: Stay up-to-date with relevant regulations, standards, and industry best practices, and ensure that clinical development activities are aligned with these requirements.
- **Issue Resolution**: Lead investigations into quality issues, non-conformances, and deviations, and implement corrective and preventive actions (CAPAs).
**Qualifications**:
- Bachelor's or advanced degree in a life science or related field.
- 6 years of experience in clinical quality assurance within the pharmaceutical, biotech, or CRO industry.
- Strong understanding of GCP (Good Clinical Practice) regulations and guidelines.
- Proven experience in managing and leading quality assurance activities in clinical development.
- Exceptional communication and leadership skills, with the ability to collaborate effectively with cross-functional teams.
?: +41 (0) 44 5514 407
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