We are seeking a skilled and experienced Business Systems Compliance -Senior Analyst to enhance and verify the compliance and computer systems validation (CSV) capabilities across systems managed by Global Development Information Management (G-DIM). This individual will be responsible for assessing the compliance status of R&D computerized systems, developing of continuous improvement / CAPA plans, training and awareness sessions on inspection readiness and acting as CSV advisor on new implementations, changes and incidents. Lead and execute CSV activities for R&D regulated computerized systems, such as EDC, CTMS, eTMF, and other clinical platforms. Develop and review validation documentation: URS, FS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrix, and Validation Plans/Reports. Ensure compliance with applicable regulations (e.g., FDA 21 CFR Part 11, EU Annex 11, ICH E6(R3)). Collaborate with cross-functional teams including QA, IT, Clinical Operations, and vendors. Conduct gap assessments, periodic reviews, and remediation planning for R&D computerized systems. Provide expert advice on data integrity, system lifecycle management, and change control. Train internal teams and clients on CSV best practices and regulatory expectations.
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Bachelors or Masters degree in Life Sciences, Computer Science, Engineering, or related field.
Minimum 5 years of experience in GxP CSV, with a strong focus on R&D systems.
In-depth knowledge of clinical trial and regulatory processes and associated computerized systems.
Proven experience with validation of SaaS/cloud-based platforms.
Strong understanding of regulatory frameworks (FDA, EMA, MHRA, ICH).
Excellent communication, documentation, and project management skills.
Ability to work independently and manage multiple projects simultaneously.
Experience working with one of these clinical systems (e.g., EDC, CTMS, eTMF) and regulatory platforms (e.g., RIM, eCTD).
Experience with vendor qualification and third-party audits.
Familiarity with Agile and SDLC methodologies.
Exposure to technologies such as NLP, LLMs, or workflow automation in life sciences.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.