Manager, Computer System Validation (CSV), QA

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
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.

Affiliate Overview

Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

What You'll Do

The Manager, Computer System Validation (CSV), QA will report to the Associate Director, Quality Assurance (QA). This position will provide quality oversight of the computer system validation lifecycle from design and implementation to retirement, ensuring compliance of GxP applications. This role will ensure that all GxP computerized systems, including Veeva, Argus, SAP, Tracelink, etc., are implemented, validated, and maintained in compliance with FDA, EMA, ICH, GAMP 5, and other Health Authority requirements. The ideal candidate will combine technical expertise in CSV, strong quality systems acumen, and exceptional cross-functional communication skills. 

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)

Where You'll Work

This position can be a hybrid role which requires in-office collaboration 2-3x per week in our San Francisco Office. This position can also be considered for U.S-based remote role, that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• 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)

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial 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

Health & Wellbeing:

• 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

Skill Development & Career Paths:

• 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