Associate Director/Director, Clinical Quality Assurance

Role Summary

The Associate Director/Director, Clinical Quality Assurance provides leadership for clinical quality systems and documentation, oversees management of Clinical Controlled Documents, develops project-specific training programs, and champions deviation and CAPA processing while supporting the Audit Program. The role emphasizes continuous process improvement across Clinical QA functions and requires collaboration with cross-functional teams.

Responsibilities

• Clinical Controlled Document Management:
  • Own and manage Clinical Quality Assurance controlled documents in Veeva QualityDocs, including SOPs and Work Instructions
  • Develop, review, and approve documents to ensure alignment with regulatory standards and industry best practices across Clinical functional areas
  • Oversee document workflows and approval status in Veeva, ensuring timely progression and resolution of delays
  • Collaborate on centralized Clinical document strategy with QED and cross-functional BBIO teams, fostering continuous improvement
• Clinical Project-Specific Training (PST):
  • Design and manage project-specific training programs, including oversight of training matrices and compliance with SOP timelines
  • Administer training activities in Veeva, partnering with existing administrators and Clinical Operations to manage ownership transitions
  • Lead QA support for PST escalations, addressing late submissions, versioning issues, and audit readiness
  • Drive process improvements and alignment, contributing to SOP updates and presenting training metrics in Quality Management Reviews
• Deviation/CAPA Champion:
  • Serve as the primary Clinical QA lead for Quality System Deviations and CAPA processes, overseeing initiation, planning, implementation, effectiveness checks, and closure to ensure compliance and timely resolution
  • Drive deviation investigations and risk assessments, collaborating with Clinical teams to perform root cause analysis and ensure alignment with SOPs and regulatory expectations
• Audit Report/Response:
  • Review audit reports and responses for completeness and quality, ensuring alignment with QED’s standards and providing actionable feedback
  • Ensure timely and compliant documentation of audit reports and responses in accordance with SOPs and regulatory expectations
• Regulatory Authority Inspection Readiness:
  • Support mock inspections, identify potential compliance gaps, and implement corrective actions, as needed
• Other duties as assigned or required

Qualifications

• 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

Skills

• 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

Education

• Bachelor’s degree in a scientific discipline or equivalent experience

Additional Requirements

• Location: This is a U.S.-based remote role with quarterly, or as-needed visits to the San Francisco office