Senior AvionX Controls Integration and Test Engineer
Boeing
PythonTCP/IP
Associate Director/Director, Clinical Quality Assurance
BridgeBio
full-time
Posted on:
Location Type: Hybrid
Location: San Francisco • California • 🇺🇸 United States
Visit company websiteSalary
💰 $170,000 - $233,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Support Clinical functional areas in their management of Clinical Controlled Documents
- Design and develop Clinical Project-Specific Training Programs
- Champion Quality System Deviation and CAPA processing and support the Audit Program
- Drive strategy and execution of Clinical Controlled Document Management
- Own and manage Clinical Quality Assurance controlled documents in Veeva QualityDocs
- Develop, review, and approve documents for regulatory standards alignment
- Oversee document workflows and approval status in Veeva
- Collaborate on centralized Clinical document strategy with QED and cross-functional BBIO teams
- Design and manage project-specific training programs
- Serve as the primary Clinical QA lead for Quality System Deviations and CAPA processes
- Support mock inspections and identify potential compliance gaps
- Review audit reports and responses for completeness and quality
- Ensure timely and compliant documentation of audit reports and responses
Requirements
- 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.
Benefits
- Market leading compensation
- 401K with 100% employer match on first 3% & 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 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical Controlled Documents managementClinical Project-Specific Training Programs designQuality System Deviation processingCAPA processingregulatory standards alignmentdocument workflows managementaudit report reviewVeeva QualityDocsGCP guidelines expertiseVeeva administration
Soft skills
collaborationrelationship-buildingnegotiationsolution-based approachesverbal communicationwritten communicationtime managementprioritizationpressure management
Certifications
Bachelor’s degree in a scientific discipline
