Senior Manager – Computer Systems Assurance & Validation

Senior Manager – Computer Systems Assurance & Validation

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.

Responsibilities

• 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.
• 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.

Preferred Qualifications

• 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.