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Associate Director / Director, Clinical Quality Assurance

Associate Director / Director, Clinical Quality Assurance

BridgeBioSan Francisco, CA, United States
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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

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    Quality Assurance Associate • San Francisco, CA, United States

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