Job Description

This role is hybrid on-site 3x per week in Redwood City

We’re seeking an experienced and strategic Associate Director, Clinical Quality Assurance with expertise in Process Development & Documentation. In this leadership role, you’ll drive the development, implementation, and optimization of GCP, GVP, and GLP processes and SOPs that support clinical research excellence and regulatory compliance.

What You’ll Do

• Lead cross-functional initiatives to develop, document, and maintain clinical SOPs aligned with regulatory requirements.
• Serve as a process compliance advisor to clinical teams, participating in SOP and study document reviews.
• Manage SOP lifecycle planning and ensure timely updates using a risk-based approach.
• Drive continuous improvement of the Clinical Quality Management System (CQMS).
• Support inspection readiness and regulatory inspections (GCP, GLP, GVP, GMP).
• Conduct internal audits and vendor qualifications with a focus on process documentation.
• Investigate non-compliance events and lead CAPA implementation and tracking.
• Analyze quality metrics and provide insights into process improvement opportunities.
• Mentor and develop junior team members, fostering a culture of quality and accountability.
• Stay ahead of regulatory trends and best practices in process development and clinical quality.

What We’re Looking For

• Bachelor’s degree in Life Sciences, Pharmacy, or related field.
• 10+ years of experience in clinical quality, with a strong focus on SOP development and process management.
• Proven expertise in GCP, GLP, GVP compliance and regulatory inspection support.
• Strong technical writing and documentation skills.
• Deep understanding of quality systems and clinical operations.
• Proficient in Microsoft Office Suite; experience with quality systems a plus.
• Leadership, collaboration, and communication skills essential.

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