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:
  • 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.
Requirements:
  • 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.
Join the dynamic team and contribute to our mission of improving patient lives through innovative therapies. Apply now with your updated CV.