Managers

The salary range for this role performed in California is $200,304 to $220,000 per year. Compensation will ultimately depend on job-related factors including skills and experience. Requires a Master's degree in Management Information Systems, Information Technology, or a closely related field, and at least two years of hands-on experience in planning, executing, and leading Product Validation and Quality initiatives within a software company dedicated to the life sciences sector, with a strong emphasis on cloud-based solutions and continuous cloud assurance programs. Experience must include: analyzing and applying FDA Regulations, including a specialized focus on 21 CFR Part 11, and a proven ability to seamlessly integrate regulatory procedures and best practices into software development workflows; a demonstrated track record of successfully conducting Computer System Validation, showcasing expertise in adhering to GAMP 5 principles and GxP practices, specifically tailored to the unique needs of life sciences software; proven history of designing meticulous Computer System Validation plans that not only ensure compliance but also align with the strategic objectives of the software company, and adeptness in confidently and effectively presenting these plans; engaging with life sciences clients on a technical level, adeptly capturing feedback, proactively addressing challenges, and iteratively refining software solutions to exceed their expectations; provision of comprehensive training on essential regulations and requirements, both internally and externally, thereby fostering a culture of regulatory compliance and excellence within the software company's ecosystem; and the research and analysis of emerging trends and technological advancements in both the software and life sciences industries. Please send resume referencing job title and location to