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Head of Compliance Clinical Quality Assurance
hace 2 meses
Job Purpose: We are seeking a highly skilled and experienced professional to join our team as the Head of Compliance Clinical Quality Assurance. As a key member of our Development Team, you will be responsible for ensuring the highest standards of quality and compliance in our clinical processes.
Key Responsibilities:
- Drive a culture of quality and excellence across Development by forging strong business partnerships and implementing effective quality strategies.
- Guide Quality System Owners and Business Process Owners in the development of robust clinical process changes, considering interdependencies and risk management.
- Collaborate closely with Business Process Owners to prepare for audits, actively participate, and support the formulation of a comprehensive CAPA plan.
- Work closely with the Head of GCP Inspection Management and GCP Inspection Project Manager(s) to identify potential risk areas and ensure seamless process execution.
- Guide Business Process Owners in preparing for specific presentations and deliverables requested during inspections.
- Proactively address potential gaps and risks while identifying valuable opportunities for continuous improvement and driving data-generated insights for clinical processes.
Your Experience:
- Master's degree in life sciences, healthcare, M.D, Ph.D, or MBA is desired.
- At least 10 years of involvement in regulated activities (GCP/PH), clinical development, and/or QA position in the pharmaceutical drug development.
- Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
