Director of Clinical Quality Assurance - Remote

Overview

The Director, Clinical Quality Assurance will define and execute the Clinical Controlled Document Management strategy, supporting Clinical functional areas in their management of Clinical Controlled Documents.

In Short

• Lead Clinical Controlled Document Management strategy.
• Develop and review Clinical Controlled Documents.
• Ensure compliance with regulatory standards.
• Collaborate with GMP QA for document management.
• Act as a single point of contact for clinical areas.
• Monitor document approval workflows.
• Foster a culture of continuous improvement.
• Design project-specific training programs.
• Support regulatory inspections and compliance.
• Manage training activities within Veeva.

Requirements

• 6+ years of experience in GCP practice area.
• 2+ years of Veeva administration experience preferred.
• Strong negotiation and problem-solving skills.
• Ability to handle multiple projects simultaneously.
• Excellent verbal and written communication skills.
• Bachelor's degree in a scientific discipline or equivalent experience.
• Expertise in GCP guidelines.

Benefits

• Patient Days to learn from individuals affected by conditions.
• A culture that prioritizes patient needs and scientific integrity.
• Access to learning and development resources.
• Market-competitive compensation and benefits package.
• Flexible PTO.
• Rapid career advancement opportunities.
• Commitment to Diversity, Equity & Inclusion.