Senior Director of Quality Assurance - Remote

Overview

The Senior Director of Quality Assurance at GondolaBio is responsible for overseeing Good Clinical Practice (GCP) activities related to clinical trials, ensuring compliance with regulatory requirements and industry standards.

In Short

• Lead development and maintenance of Quality Management System procedures.
• Ensure inspection readiness and support audits by external sources.
• Manage direct reports and consultants in Clinical Quality Assurance objectives.
• Coordinate documentation of quality event management.
• Provide GCP leadership and expertise to clinical study teams.
• Author and maintain QA Standard Operating Procedures.
• Support training oversight in collaboration with functional leads.
• Plan and conduct internal and external service provider audits.
• Work with GMP QA Team on enterprise-wide QMS topics.
• Other duties as assigned.

Requirements

• Expertise in Quality Management System development.
• Strong relationship-building and collaborative skills.
• Excellent negotiation and problem-solving abilities.
• Ability to handle multiple projects and time demands.
• Thorough knowledge of regulations such as 21CFR and ICH guidelines.
• Bachelor's degree in a scientific discipline; Master's preferred.
• 8+ years in a GCP practice area.
• Expertise with GCP guidelines.
• Experience with Veeva platform preferred.

Benefits

• Patient Days for direct engagement with impacted individuals.
• A culture focused on patient-first values and transparency.
• Decentralized model for empowering program teams.
• Opportunities for career ownership and advancement.
• Collaborative, fast-paced, data-driven work environment.
• Access to learning and development resources.
• Market-competitive compensation and benefits package.
• Flexible PTO.
• Rapid career advancement for strong performers.
• Commitment to Diversity, Equity & Inclusion.