Associate Director/Director, Clinical Quality Assurance

Role Summary

Associate Director/Director, Clinical Quality Assurance responsible for supporting Clinical functional areas in management of Clinical Controlled Documents, designing and developing Clinical Project-Specific Training Programs, and championing Quality System Deviations and CAPA processing, with a focus on continuous process improvement.

Responsibilities

• Clinical Controlled Document Management: Own and manage Clinical QA controlled documents in Veeva QualityDocs (SOPs and Work Instructions); develop, review, and approve documents to ensure regulatory alignment; oversee document workflows and approvals in Veeva; collaborate on centralized Clinical document strategy with QED and cross-functional BBIO teams.
• Clinical Project-Specific Training (PST): Design and manage project-specific training programs; oversee training matrices and SOP timelines; administer training activities in Veeva; manage ownership transitions with Clinical Operations; lead QA support for PST escalations; drive process improvements and SOP updates; present training metrics in Quality Management Reviews.
• Deviation/CAPA Champion: Lead Quality System Deviations and CAPA processes; oversee initiation, planning, implementation, effectiveness checks, and closure; conduct root cause analysis and ensure regulatory alignment.
• Audit Report/Response: Review audit reports and responses for completeness and quality; ensure documentation in accordance with SOPs and regulatory expectations.
• Regulatory Authority Inspection Readiness: Support mock inspections; identify gaps and implement corrective actions as needed.
• Other duties as assigned or required.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience
• Minimum 6 years in a GCP-regulated environment; Clinical Quality Assurance or related role preferred
• Expertise in applicable GCP guidelines and regulatory expectations
• 2+ years of experience with Veeva administration highly preferred
• Strong collaboration and relationship-building skills across internal teams and external vendors
• Skilled in negotiation and solution-based approaches to complex challenges
• Excellent verbal and written communication; able to manage multiple priorities under pressure