Associate Director/Director, Clinical Quality Assurance

Base pay range

$170,000.00/yr - $233,000.00/yr

This is a U.S.-based remote role that will require quarterly, or as needed visits to the San Francisco Office.

What You'll Do

• Reporting to the Senior Director, Clinical Quality Assurance, supports Clinical functional areas in the management of Clinical Controlled Documents.
• Designs and develops Clinical Project-Specific Training Programs and serves as a champion for Quality System Deviation and CAPA processing; supports the Audit Program.
• Champions continuous process improvement within Clinical Quality Assurance.

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 regulatory alignment; oversee document workflows and approval status; 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, ensure SOP timelines compliance; administer training activities in Veeva; manage ownership transitions; 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 from initiation to closure; perform risk assessments and root cause analysis with Clinical teams to ensure regulatory alignment.
• Audit Report/Response: Review audit reports and responses for completeness and quality; ensure timely documentation in accordance with SOPs and regulatory expectations.
• Regulatory Authority Inspection Readiness: Support mock inspections, identify compliance gaps, and implement corrective actions as needed.
• Other duties as assigned or required.

Who You Are

• 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.

Rewards & Benefits

• Market leading compensation
• 401K with employer match on the first 3% and 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with premiums covered for employee and dependents
• Mental health support via Spring Health
• Hybrid work model; unlimited flexible paid time off; paid parental leave
• Flex spending accounts; company-provided group term life & disability
• Subsidized lunch via Forkable on days worked from the office

Salary: $170,000 - $233,000 USD