Associate Director, GCP Quality and Compliance
August 21
🏡 Remote – New York
Description
• Supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures. • Performs ICH/GCP quality reviews/audits to ensure overall compliance with applicable regulations. • Builds upon the current QMS in establishing additional company standards and metrics to ensure the highest quality of services provided to clients.
Requirements
• Requires 8-10 years of experience in clinical research or pharmaceutical development with emphasis in Quality Assurance/Compliance or equivalent relevant experience and/or demonstrated competencies • Working knowledge of GCP/ICH guidelines and FDA regulations and standards • Bachelor’s degree in a science, healthcare or related field of study • Availability to travel up to 25% domestically and/or internationally • Graduate, postgraduate degree, ideally in a scientific or healthcare discipline (preferred) • CRO, Pharmaceutical and/or Medical device experience (preferred) • Supervisory/management experience (preferred)
Benefits
• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance and disability benefits • Parental leave • Paid time off for sick leave and vacation
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