We are seeking a highly experienced and dynamic Executive Director (ED) of Clinical Quality Assurance (QA) to lead the Clinical QA department for Fortvita, a growing biotechnology organization with multiple oncology trials at various stages of development. The ED will oversee the design, implementation, and continuous improvement of quality assurance systems to ensure that all clinical trial activities meet the highest standards of regulatory compliance, data integrity, and patient safety. This senior leadership role requires a strategic thinker with a deep understanding of clinical development, oncology, and regulatory frameworks.
The ideal candidate will have a proven track record in clinical quality assurance within the biotech or pharmaceutical industry, preferably with extensive experience managing oncology trials. This is a key role in driving the success of our clinical development programs while ensuring that all clinical trials are conducted in accordance with Good Clinical Practices (GCP), FDA, EMA, and ICH guidelines.
Key Responsibilities:
Leadership & Strategy:
Clinical Trial Oversight:
Regulatory Compliance & Auditing:
Continuous Improvement & Risk Management:
Collaboration & Communication:
Qualifications & Experience:
Education:
Experience:
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