OneTrust

Enterprise Quality R&D Clinical Computer System Validation Manager

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: New Jersey, Pennsylvania • 🇺🇸 United States

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Salary

💰 $102,000 - $177,100 per year

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.
  • Responsible for planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications.
  • Support internal audits and Health Authority regulatory inspections.
  • Responsible for the approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use.
  • Attend project team meetings and provide EQ compliance guidance and support to project and base business support team members.
  • Lead globally diverse teams in an inclusive environment.

Requirements

  • 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
  • Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  • Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year

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 LearningSDLC Quality ManagementcGMP regulations
Soft skills
technical expertiseprocedural guidancestakeholder alignmentplanningtask allocationresource allocationteam coordinationleadershipinclusive environmentcommunication