Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager
On-siteBeerse, Flanders, Belgium or Allschwil, Basel-Landschaft, Switzerland
Job Summary
Ensure all J&J quality standards and global regulatory requirements are met for enterprise-wide systems by guiding project teams through the end-to-end lifecycle of design, development, implementation, and maintenance. Own the quality approach for systems, integrating early quality involvement into activities and building controls within applications while using automation whenever feasible. Plan, allocate resources, and execute validation activities for GxP systems, supporting internal audits and Health Authority regulatory inspections. Approve SDLC validation documentation deliverables, including system implementation and change releases for production use, and provide technical guidance to internal and external stakeholders. Lead globally diverse teams in an inclusive environment as a trusted partner across the Enterprise Quality organization.
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/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
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