Senior Manager, Computer Systems Assurance & Validation

The Position

The Senior Manager of Computer Systems Assurance and Validation is responsible for developing and managing computer system validation and assurance activities to ensure compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and industry best practices. This role will drive the adoption of a risk-based approach aligned with CSA principles, ensuring that GxP systems meet intended use while optimizing efficiency and compliance. This individual will have one direct report with the potential to expand the team as business needs evolve. The role will entail working cross-functionally with IS, Quality, Manufacturing, Regulatory, Clinical, and other stakeholders to establish and maintain validation programs for GxP applications, cloud-based solutions, and software tools used in regulated environments.

This role is based in Pasadena, California, with an expectation to be in office 5 days a week.

Responsibilities

• Leadership & Compliance Oversight
  • Work closely with Quality Assurance and IS leaders to develop and implement CSA/CSV strategies and frameworks to ensure compliance with global regulatory requirements and industry best practices.
  • Manage the transition from traditional CSV to CSA methodologies, incorporating risk-based testing and automation where applicable to reduce unnecessary documentation while maintaining compliance.
  • Maintain awareness of evolving regulatory expectations and ensure company policies and procedures are updated accordingly.
  • Act as a subject matter expert (SME) on validation and compliance topics, advising internal stakeholders on best practices for software validation and assurance.
  • Identify opportunities to enhance validation processes through automation, documentation efficiency, and risk-based approaches.
• Validation & Assurance Activities:
  • Manage and execute the validation lifecycle for GxP systems, including planning, risk assessment, testing, reporting, and periodic review.
  • Authoring and executing validation activities (e.g., documenting system requirements, validation plans, URS, test scripts, traceability matrices, validation reports) are created, reviewed, and approved in accordance with regulatory expectations.
  • Develop and manage a risk-based testing strategy that aligns with CSA principles to optimize validation efforts.
  • Establish procedures for ongoing system assurance, including periodic reviews, change management, and system decommissioning.
  • Provide guidance and training to teams on CSA/CSV methodologies, regulatory expectations, and best practices.
  • Support internal and external audits, regulatory inspections, and remediation efforts related to software validation and compliance.

Requirements:

• Bachelor’s degree in Computer Science, Information Systems, Life Sciences, Engineering, or a related field.
• 8+ years of experience in CSV/CSA within the pharmaceutical, biotechnology, or medical device industry.
• Strong understanding of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH guidelines).
• Experience in implementing CSA principles and a risk-based approach to validation.
• Demonstrated ability to manage validation projects and collaborate with cross-functional teams.
• Excellent communication, leadership, and problem-solving skills.
• Experience with cloud-based systems, SaaS validation, and IT compliance frameworks.

Preferred:

• Advanced degree in a relevant field.
• Experience working with Quality Management Systems (QMS) and electronic validation tools.
• Knowledge of Agile, DevOps, and automation tools in the validation space.
• Experience supporting regulatory inspections and audits.