Senior Director of Clinical QA

Job Summary

Providing strategic and operational Quality Assurance leadership, the remote Senior Director of Clinical QA will manage multiple global clinical trials, ensuring compliance with Good Clinical Practice (GCP) and advancing the CQA mission through proactive quality strategies and continuous improvement.

Key responsibilities:

• Serve as a senior Quality partner to clinical study teams, offering guidance on GCP and related regulations while attending study team meetings and quality governance forums
• Lead the development and implementation of Clinical Study Quality Plans, ensuring subject safety, data integrity, and compliance across assigned studies and vendors
• Oversee GCP compliance audits of high-risk clinical vendors/sites and manage the communication of audit findings and CAPA commitments to senior stakeholders

Required qualifications:

• Bachelor's degree in a life science, nursing, pharmacy, or related field; advanced degree preferred
• 12+ years of experience in a regulated environment, with at least 7 years in clinical quality assurance and oversight of global clinical trials
• Proven experience leading clinical quality strategy and hosting health authority inspections
• Expert understanding of GCP requirements and the ability to apply them strategically across clinical programs
• Strong leadership and interpersonal skills, with the ability to influence senior stakeholders and drive alignment across cross-functional teams