Manager, Computer System Validation (CSV), QA

BridgeBio Pharma • San Francisco, CA

63d • $130,000 - $160,000

About The Position

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask 'why not?' and help reengineer the future of biopharma.

Requirements

• Bachelor’s or Master’s degree in software, computer engineering, or technical field
• 8+ years of experience in quality systems development and maintenance within clinical and commercial-stage pharmaceutical or biotech companies
• Excellent attention to detail and strong organizational skills
• Effective communication skills both written and verbal
• Demonstrated expertise in GxP computerized system validation (CSV/CSA) and system lifecycle management
• Strong working knowledge of regulatory requirements, including: 21 CFR Part 11, EU Annex 11, ICH Q10, GAMP 5
• Hands-on experience with computer system validated platforms (Veeva eTMF, Quality, QMS, RIM; SAP; Argus; Tracelink)
• Experience developing GxP SOPs and training personnel on compliance requirements
• Ability to work independently and collaboratively within a team
• Ability to influence and drive cross-functional teams
• Familiarity with risk-based validation methodologies (CSV/CSA)

Responsibilities

• Provide QA oversight of the GxP computer system validation lifecycle, ensuring ongoing compliance and validated state through design, configuration, updates, and maintenance
• Review and approve IT change control and validation deliverables, including protocols, test scripts, and reports of the GxP validated system
• Evaluate risk assessments and determine the impact of changes/updates on user experience, system performance, and compliance
• Participate, review, and approve periodic system reviews and release management activities, identifying and remediating compliance gaps
• Collaborate with IT, cross-functional stakeholders such as business owners, to establish and enforce requirements for system validation, data integrity, and ongoing system maintenance
• Drive continuous improvement initiatives for QMS and validated GxP systems
• Support regulatory inspections and audits, ensuring adherence to 21 CFR Part 11, EU Annex 11, GxP, and other regulatory frameworks
• Support inspection remediation activities and CAPA management through timely resolution and closure
• Collaborate with cross-functional teams to optimize workflows, reporting capabilities, and system usability for business and compliance needs
• Review and approve GxP-computer system SOPs, and support end-user training to ensure proper adoption and compliance
• Serve as QA CSV subject matter expert (SME) and provide guidance on risk-based validation strategies (CSV/CSA)

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
• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees