Senior Manager, Computer System Validation QA

bridgebio; United States; On-site; USD 160,000 - 230,000; Full time

Job summary

BridgeBio is seeking a Senior Manager, CSV QA to oversee the GxP computer system validation lifecycle across design, implementation and retirement. You will ensure validation of GCP/GVP systems and maintain compliance with Health Authority requirements.

The role partners with IT, QA Ops, and business owners to implement risk-based validation, data integrity, and ongoing system maintenance, while supporting audits and CAPA processes.

Qualifications

• 8+ years of quality systems development in pharma/biotech.
• Expertise in GxP computerized system validation/assurance (CSV/CSA).
• Knowledge of 21 CFR Part 11, EU Annex 11, ICH GCP, EU GVP.
• AI/Large Language Models governance experience is a plus.

Responsibilities

• Provide QA oversight of the GCP/GVP validation lifecycle from design to retirement.
• Review and approve risk assessments to determine scope of validation.
• Review and approve IT change control and validation deliverables (protocols, test scripts, reports).
• Participate in periodic system and user reviews; remediate compliance gaps.
• Collaborate with IT and business owners to enforce validation requirements and data integrity.
• Support audit program; participate in audit and CAPA reviews.
• Project manage implementation and enhancement of GCP/GVP and QMS systems.
• Drive continuous improvement of QMS and validated GxP systems.
• Support inspection readiness and regulatory inspections as QA CSV SME.

Skills

Quality systems

GxP CSV/CSA

Regulatory compliance

Cross-functional collaboration

AI governance (GxP)

Education

Bachelor's or Master's in software/engineering/technical field

Job description

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. At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

Who You Are

The Senior Manager, Computer System Validation (CSV), QA will report to the Sr. Director, QA Ops and Inspection Management. 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 GCP/GVP computerized systems are validated for intended use, and maintained in compliance with Health Authority requirements.

This position partners cross-functionally with IT, GMP Quality Assurance, and functional area system owners, business process owners, and service providers to apply a documented, risk-based approach to validation and compliance.

Responsibilities

• Provide QA oversight of the GCP/GVP computer system validation lifecycle, ensuring ongoing compliance and a validated state through design, configuration, updates, and maintenance.
• Review and approve computer system risk assessments to determine the scope and level of validation required for system implementation.
• Review and approve IT change control and validation deliverables, including protocols, test scripts, and reports of the GCP/GVP validated system.
• Participate, review, and approve periodic system and user reviews, identifying and remediating compliance gaps.
• Collaborate with IT and cross-functional stakeholders such as business owners, to establish and enforce requirements for system validation, data integrity, and ongoing system maintenance.
• Support the computer system audit program by participating in audit activities including audit report and CAPA reviews.
• Project manage the implementation, configuration, and continuous enhancement of GCP/GVP and QMS computer systems.
• Drive continuous improvement initiatives for QMS and validated GxP systems.
• Support inspection readiness and regulatory inspection activities including serving as a QA CSV subject matter expert and response/CAPA management through timely resolution and closure.
• Review and approve GxP-computer system and business process procedures, and support end-user training to ensure proper adoption and compliance.
• Support organizational artificial intelligence (AI) governance as the GCP/GVP Quality representative

Education, Experience & Skills 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/assurance (CSV/CSA) and system lifecycle management.
• Working knowledge of applicable electronic-record, computerized-system, data-integrity, clinical-practice, and pharmacovigilance requirements and guidance, including 21 CFR Part 11, relevant FDA predicate rules, EU Annex 11 principles, ICH GCP, EU GVP, and risk-based lifecycle practices such as GAMP.
• Experience developing GxP SOPs and training personnel on compliance requirements.
• Experience with Artificial Intelligence (AI)/ Large Language Models (LLMs) and AI Governance in a GxP setting is a plus.
• Ability to work independently and collaboratively within a team.
• Ability to influence and drive cross-functional teams.
• Travel into the San Francisco office quarterly for remote employees.

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, l