OneTrust

Enterprise Quality R&D Clinical Computer System Validation Manager

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Mechelen • 🇧🇪 Belgium

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Job Level

SeniorLead

Tech Stack

JenkinsSDLCSelenium

About the role

  • Ensure that all J&J quality standards and global regulatory requirements are being met.
  • Ensure that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible.
  • Own the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.
  • Provide technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders.
  • Plan, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications.
  • Support internal audits and Health Authority regulatory inspections.
  • Author approval of SDLC validation documentation deliverables, including the approval to release system implementation and/or changes for production use, attending project team meetings and providing EQ compliance guidance.

Requirements

  • Bachelor’s or equivalent degree in Computer Science, Information Systems, Business Administration, Science, Engineering or another related field is required.
  • 8-10 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities.
  • Experience in running large scale end-to-end Validation programs is required such as LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and Change Control.
  • Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports.
  • Proficiency using the following tools is highly desirable: 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, is required.
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Computerized System ValidationValidation protocolsChange RequestsSOPsValidation PlansValidation ReportsArtificial IntelligenceMachine LearningcGMP regulationsSDLC Quality Management
Soft skills
technical expertiseprocedural guidancestakeholder alignmentplanningtask allocationcoordinationcommunicationaccountabilitycollaborationproblem-solving