Manager, Computer Systems Assurance and Validation

Responsibilities

• 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.
• 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.

Pay

Wisconsin pay range: $110,000 USD - $135,000 USD
California pay range: $130,000 USD - $150,000 USD

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.

Qualifications

Candidates must have current, valid authorization to work in the country where this role is located.

Equal Opportunity Employer

Arrowhead is an equal opportunity employer and does not discriminate against applicants due to race, religion, national origin, age, gender, sexual orientation, disability, veteran status, or any other classification protected by law.