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Clinical Quality Development Team Lead
- Posted 16 July 2023
- LocationSwitzerland
- Job type Permanent
- Reference90046
- Contact NameDuncan Johnston
Job description
Quality Team Lead – Clinical Development (Associate Director)
BioTalent is supporting a biopharmaceutical company, committed to advancing research in oncology and infectious diseases. They are currently seeking a Clinical Development Quality Team Lead; in this role, you will lead the Clinical Development Quality Team, ensuring compliance with our Quality Management System (QMS), regulatory requirements, and maintaining readiness for Good Clinical Practice (GCP) inspections.
Responsibilities:
BioTalent is supporting a biopharmaceutical company, committed to advancing research in oncology and infectious diseases. They are currently seeking a Clinical Development Quality Team Lead; in this role, you will lead the Clinical Development Quality Team, ensuring compliance with our Quality Management System (QMS), regulatory requirements, and maintaining readiness for Good Clinical Practice (GCP) inspections.
Responsibilities:
- Develop and implement a proactive, risk-based Clinical Quality Strategy.
- Plan and manage Clinical Development Quality activities across our portfolio.
- Lead and manage a team of Clinical Development Quality Leads, providing project-level quality support.
- Contribute to the selection and qualification process of preferred CROs/Vendors.
- Provide oversight of clinical development quality and participate in CRO/Vendor Governance meetings.
- Drive alignment on clinical development quality practices across projects and trials.
- Oversee compound-specific Regulatory Authority Inspections and Due Diligence activities.
- Support the Audit/CAPA process of Clinical Development Quality Leads.
- Minimum 15 years' experience in Clinical Quality, with at least 10 years in a mid-size biopharmaceutical company.
- Master's degree in Science or related field.
- Demonstrated ability to bring significant changes to a Clinical Quality Management organization.
- Experience in strategic partnering with senior leaders and quality representatives.
- Comprehensive knowledge of data integrity, risk assessment, and risk mitigation.