Senior Director, Global Clinical Quality Assurance - Remote

Overview

The Senior Director of Global Clinical Quality Assurance will lead the global clinical quality assurance strategy and ensure compliance with Good Clinical Practice (GCP) and regulatory standards, playing a vital role in transforming cancer therapy.

In Short

• Lead global quality assurance strategy and execution.
• Ensure compliance with GCP and regulatory standards.
• Manage audits and inspections for clinical sites and service providers.
• Collaborate with cross-functional teams to align quality assurance strategies.
• Serve as the primary liaison with regulatory authorities.
• Establish and manage Pharmacovigilance Quality Assurance processes.
• Drive alignment and implement compliant solutions.
• Engage in hands-on leadership for clinical quality initiatives.
• Manage complex clinical quality projects from end-to-end.
• Communicate effectively on complex issues to influence outcomes.

Requirements

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
• 15+ years of experience in clinical quality assurance.
• Certification in Quality Assurance (CQA or RQAP-GCP) preferred.
• Experience with Phase 3 study quality assurance.
• Extensive knowledge of ICH GCP and global regulations.
• Strong project management skills.
• Excellent communication and team collaboration skills.
• Ability to travel 15% as needed.

Benefits

• Flexible work environment.
• Opportunity to make a difference in patient lives.
• Work with a talented and dedicated team.
• Inclusive and professional work culture.