Senior Manager, Computer System Validation (CSV), QA

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

• A 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.