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Hybrid Enterprise Quality R&D Clinical Computer System Validation Manager
Posted 2 months ago
About the role
- CSV Manager ensuring compliance and quality validation for enterprise systems at Johnson & Johnson. Leading project teams and maintaining regulatory standards in healthcare technology.
Responsibilities
- 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
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