Senior Manager, GxP Computerized Systems Auditing

Role: Senior Manager, GxP Computerized Systems Auditing, overseeing a global risk-based audit program for GxP-regulated computerized systems supporting clinical, manufacturing, and quality processes. Objectives include providing independent quality oversight, assessing compliance risks, conducting internal and third-party audits, and supporting inspection readiness. Responsibilities encompass developing audit strategies, leading audits of software vendors and cloud providers, evaluating cybersecurity and data integrity controls, and ensuring adherence to global regulations such as 21 CFR Part 11 and EU GMP Annexes. The role requires collaboration with Quality, IT, Manufacturing, Clinical, and Regulatory teams, and involves up to 25% travel (domestic/international). Qualifications include a bachelor's degree (advanced degree or professional certification preferred), 5+ years of experience auditing GxP computerized systems, with strong knowledge of regulatory standards, validation, data integrity, and cybersecurity. Experience leading complex audits, supporting inspections, and managing vendor assessments is essential. The role demands technical writing, stakeholder management, and influencing skills, with the ability to prioritize in a fast-paced, global environment. Work setup is hybrid or remote, based on location.