Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager
On-siteRaritan, New Jersey, United States or Horsham, Pennsylvania, United States
Job Summary
Lead the project team through the end-to-end lifecycle of enterprise-wide systems, ensuring all J&J quality standards and global regulatory requirements are met. Embed early quality involvement in design and development activities, building controls within applications and utilizing automation where feasible. Own the quality approach for systems, providing technical and procedural guidance to project teams while aligning with internal and external stakeholders. Plan, allocate resources, and execute coordination for validation activities for GxP systems, including supporting internal audits and Health Authority regulatory inspections. Approve SDLC validation documentation deliverables, including release approvals for production use, and attend project meetings to provide compliance guidance. Guide diverse teams in an inclusive environment, serving as a trusted partner across the Enterprise Quality organization to recommend improvements for senior-level stakeholders.
Required Qualifications
- Bachelor's or equivalent degree in Computer Science, Information Systems, Business Administration, Science, Engineering or another related field
- 8-10 years of progressive experience in the pharmaceutical/medical device/biotech industry
- Direct experience in Computerized System Validation activities
- Experience in running large scale end-to-end Validation programs
- Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports
- Proficiency using the following tools: JIRA, HPALM, Xray, Qtest, Jenkins, Selenium
- Direct experience working in a software development environment using Agile, SAFe, CI/CD
- Direct experience in Artificial Intelligence (AI) and Machine Learning (ML)
- Direct experience in CSV Quality and/or CSV for R&D systems
- Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820
- Knowledge of SDLC Quality Management process and Computerized System Validation/Computerized System Assurance principles
- Proficiency in the English language, both written and oral
- Up to 10% travel both international and domestic
Desired Qualifications
- Experience in Testing Management tools like HPALM, JIRA with Xray, Selenium
- Implements elements of an effective quality management system to the organization and its technology solutions
- Working knowledge/experience in utilization of AI and digital tools
- Able to apply digitization tools and techniques to automate, simplify, digitize and enhance software development and validation processes
- Understands and applies best practices for architecting effective data solutions and frameworks that enable high quality data
- Working knowledge of other Global Regulations like EU Annex 11, SOX, HCC, Security & Privacy, ISO
- Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks
- Knowledge of the following technologies and methodologies: Agile, SAFe, CI/CD, RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain, Kubernetes, XaaS, SaMD
- Understands data integrity needed throughout the lifecycle of a technology solution
- Defines strategy for testing according to the risk assessment
- Experience in Testing Management tools like HPALM, JIRA with Xray, Selenium
- Implements elements of an effective quality management system to the organization and its technology solutions
- Working knowledge of other Global Regulations like EU Annex 11, SOX, HCC, Security & Privacy, ISO
- Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks
- Knowledge of the following technologies and methodologies is highly desirable: Agile, SAFe, CI/CD, RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain, Kubernetes, XaaS, SaMD
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