Director, GCP Quality Operations - Remote

Overview

The Director, GCP Quality Operations is responsible for providing expertise and leadership in Good Clinical Practice Regulations and Pharmacovigilance, ensuring patient safety and data integrity while supporting compliance and continuous improvement in clinical trials.

In Short

• Lead GCP Quality Operations for clinical trials.
• Ensure compliance with global regulations and best practices.
• Support Quality Assurance Leadership in quality framework execution.
• Act as a point of contact for clinical quality activities.
• Monitor vendor compliance and quality issues.
• Facilitate quality issue management and corrective actions.
• Participate in inspection readiness and execution efforts.
• Drive continuous improvement and risk management strategies.
• Engage with cross-functional teams to promote quality standards.
• Manage day-to-day operational issues within Quality.

Requirements

• Bachelor’s degree in life sciences or quality; advanced degree preferred.
• 10+ years of GCP/GLP/GVP quality risk management experience.
• Excellent communication, negotiation, and problem-solving skills.
• Experience in a pharmaceutical company's Quality Assurance role preferred.
• Ability to function autonomously in a matrix environment.
• Strong strategic planning and creative problem-solving capabilities.
• Willingness to travel up to 25%.
• Ability to convey complex information to diverse audiences.
• Experience working with cross-functional departments.
• Knowledge of industry quality trends and regulations.

Benefits

• Competitive salary range of $200,000 - $215,000.
• Comprehensive benefits package.
• Opportunity to work in a mission-driven organization.
• Flexible work environment with remote options.
• Support for professional development and growth.
• Engagement in meaningful work focused on patient outcomes.
• Collaborative and inclusive workplace culture.
• Access to the latest technology and quality assurance metrics.
• Participation in a diverse and innovative team.
• Commitment to employee well-being and respect.