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Johnson & Johnson Technology Quality Lead
Raritan, New Jersey
Requisition ID: 3738180216
Johnson & Johnson is currently recruiting for a Technology Quality Lead. This position’s primary location will be at Raritan, New Jersey. There will also be a potential of 10% domestic travel required.
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Leading the Quality and Computer System Validation (Q-CSV) of Enterprise wide systems aligning with IT strategies deployed in our regulated environment.
- Review and approval of system requirements, specifications, and trace matrices, data flow mappings from acquisition to reporting from a Q-CSV perspective.
- Authoring computer validation deliverables from Compliance Analysis Plans to various others as needed.
- Reviewing and approving the execution of validation test scripts.
- Act as Software validation project manager coordinating and maintaining project plan, resources, timelines, and milestone delivery as needed.
- Provide technical computer engineers guidance and support aligned with applicable regulations and JJTQ SOPs
Accountable/Responsible for leading the validation of systems used across J&J Technology in regulated environments leading the following aspects of regulatory systems validations:
- Validation project manager coordinating and maintaining project plan, resources, timelines, and milestone delivery.
- Creation of system requirements, specifications, and trace matrices, data flow mappings from acquisition to reporting.
- Authoring computer validation plans, test scripts, SOPS, and reports.
- Directing the execution and review of validation test scripts.
- Leading the review of Compliance System SOPs & periodic reviews.
- Maintaining a validation roadmap for compliance systems including active validations, upcoming validation requests, periodic reviews, SOPs, and planned audit activities.
- Performing business analysis and regulatory assessments of new informatics systems being requested for use supporting QMS.
- Contributing to a variety of Agile SW projects to improve productivity and efficiency and further the success of the business.
- Engage in a dialogue with key colleagues and stakeholders, identify opportunities; business and user needs and translate them in specific actions, and projects at various levels.
- Provide computer system validation support and Lead compliance efforts of designated systems in portfolio.
- Act as point of contact with Compliance on computer system audits/inquires for designated systems.
- Provide basic GxP and 21 CFR Part 11 training to colleagues locally
- Computer science and quality background or Regulated environment and system administration.
- Understanding of Software Defined Data Centers.
- Working knowledge and hands on experience with Jira/xray/Bitbucket/j-bhave/artifactory/jenkins.
- Minimum of 8 years of relevant experience with Bachelor’s Degree or 6 years of relevant experience with a Masters/Advanced Degree in Computer Science, Engineering, scientific related discipline (Chemistry, Biology, etc) or equivalent is required.
- Knowledge SAP and HP ALM Required.
- Expert knowledge of and minimum of 8 years’ experience with regulatory agency regulations such as GLPs and predicate rule, 21 CFR Part 11, GCPs, and FDA & EMEA guidance documents.
- 5+ years’ experience authoring computer system compliance risk validations, periodic reviews, and change controls in accordance with Pharmaceutical validation SOPs, FDA GxP regulations, and 21 CFR Part 11 guidelines.
- Strong communication skills, and strong relationship development and management attributes in a global setting is required.
- Successful interactions on internal corporate QA and regulatory agency computer system audits.
- In depth knowledge of Agile and working with software development scrum teams.
- Good knowledge and understanding of VMware, systems and architectures.
- Good knowledge and understanding of testing, installation and operation of systems for intended use within a regulated environment.
- Knowledge of Annex 11 and ITIL v3 preferred.
United States-New Jersey-Raritan
Johnson & Johnson Services Inc. (6090)