Associate Director/Director of Research Quality Assurance - Remote

Overview

Disc Medicine is seeking an Associate Director/Director of Research Quality Assurance to lead the development and implementation of quality systems in compliance with GCP, GLP, and GVP.

In Short

• Lead risk-based audit program for pre-clinical, clinical, and post-approval activities.
• Ensure compliance with US and EU regulations.
• Manage internal and external audits related to GCP/GVP/GLP.
• Provide compliance management and quality oversight to external CROs.
• Track compliance status and provide management reports.
• Develop and conduct training on current regulations.
• Collaborate with internal and external stakeholders.
• Participate in project teams for quality-related matters.
• Ensure FDA inspection readiness.
• Manage contracts and activities of external contractors.

Requirements

• BS in a scientific discipline with 10+ years of experience or advanced degree with 7+ years in the pharmaceutical industry.
• Extensive knowledge of FDA, EU, ICH regulations.
• Exceptional organizational and communication skills.
• Attention to detail and ability to manage multiple tasks.
• Able to travel up to 25% internationally.
• Ability to work independently and collaboratively.

Benefits

• Comprehensive benefits package.
• Competitive compensation.
• Flexible work environment.
• Opportunities for professional development.