Clinical Risk Manager Jobs in Madison, WI (NOW HIRING)

The Position

The Manager, Computer Systems Assurance and Validation is a subject matter expert (SME) and project owner responsible for leading and executing computer system validation and assurance activities across the organization. The role drives a risk-based approach to validation through CSA principles and frameworks such as GAMP 5 to ensure GxP systems meet intended use while driving efficiency and compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11). Acting as a key cross-functional contributor, this individual partners with Quality, IS, Manufacturing, Regulatory, Clinical, and other stakeholders to influence compliance strategy, lead validation initiatives, and actively contribute to the maturation of the company's quality system and validation frameworks. The Manager serves in both an execution and oversight capacity depending on project scope, including signatory responsibilities on validation deliverables, and serves as a key technical voice in shaping how the organization approaches validation in a regulated GxP environment.

This role is based onsite 5x a week in Pasadena, CA or Verona, WI.

Responsibilities

Compliance Strategy & SME Leadership

• Collaborate with Quality Assurance and IS leaders to support the development and implementation of risk-based CSA/CSV strategies and frameworks (CSA, GAMP 5) ensuring alignment with global regulatory requirements and industry best practices.
• Drive the adoption of CSA principles for validation projects, facilitating the shift from traditional CSV approaches toward risk-based methodologies that reduce unnecessary documentation while maintaining compliance.
• Serve as subject matter expert (SME) on validation and compliance topics, advising internal stakeholders on best practices for software validation and assurance.
• Maintain awareness of evolving regulatory expectations and support updates to company policies and procedures accordingly.
• Partner with Quality and cross-functional teams to develop, refine, and mature validation processes, quality systems, and frameworks, ensuring they are scalable, audit-ready, and aligned with current and emerging regulatory expectations.

Validation & Assurance Activities

• Partner with System Owners to own and execute the full validation lifecycle for GxP systems, including planning, risk assessment, testing, reporting, and periodic review, applying a risk-based approach throughout.
• Execute and/or oversee validation activities depending on project scope and complexity, including serving as a signatory on validation deliverables where appropriate.
• Author validation deliverables (e.g., system requirements, validation plans, URS, test scripts, traceability matrices, validation reports) in accordance with regulatory expectations and internal standards.
• Apply risk-based testing strategies to optimize validation efforts and focus resources on areas of greatest compliance impact.
• Lead ongoing system assurance activities including periodic reviews, change management, and system decommissioning.

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.
• Solid understanding of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH guidelines).
• Demonstrated experience applying a risk-based approach to validation, including CSA principles and GAMP 5 frameworks.
• Proven ability to lead validation projects and serve as a cross-functional SME and collaborative partner.
• Strong communication, influence, and problem-solving skills; operates with a high degree of independence and a proactive, ownership-oriented mindset.

Preferred

• Advanced degree in a relevant field.
• Experience with validation of both pure software systems (e.g., SaaS, cloud-based applications) and equipment with embedded or integrated software components (e.g., lab instruments, manufacturing equipment).
• Experience contributing to the development or improvement of quality processes, quality systems, SOPs, or validation frameworks in a regulated environment.
• Experience working with Quality Management Systems (QMS) and electronic validation tools.
• Experience supporting regulatory inspections and audits.