Apply understanding of software applications in the life sciences domain and knowledge of the intersection of technology and life sciences to work in a technical leadership role for our company, where we provide crucial comprehensive technology solutions for life sciences companies. Develop products and ensure compliance to applicable life sciences industry regulations. Lead a Team that works collaboratively across functions with Quality, IT, Business partners, and Vendors to plan, coordinate, and execute CSV activities utilizing a risk-based approach. Author, review, and approve CSV deliverables including, but not limited to, vendor assessments, change controls, system risk assessments, validation plans, user and/or functional requirements specification, configuration specifications, IQ/OQ/PQ protocols, traceability matrix, summary reports and applicable SOPs (System Administration and User/Operations). Monitor industry developments and stay up-to-date with regulatory requirements and industry best practices. Provide training and ensure that the Team adopts best practices related to CSV and computerized systems validation. Ensure the maintenance of validated state of internal and client supported GxP systems, including periodic review and release management based on continuous cloud assurance model. Provide Quality oversight and approval of periodic user access and audit trail reviews. Contribute to Celito QMS entire life cycle development, from process definition and design, system review and development testing for functionality and User Interface (UI), to validation, training, and system support documentation. Lead and manage the QMS processes including Controlled Document Management, Learning Management (Training), Deviation/Event Investigation, Corrective and Preventive Action (CAPA), and Change Control Management. Work collaboratively across Teams to ensure that computerized systems are validated and maintained in a compliant and efficient manner. Support internal and external audits related to computerized systems, providing documentation and guidance as necessary. May work partially from home within commuting distance of Redwood City, CA office.

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 careers@celitotech.com.