Johnson & Johnson Careers
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Manager ERP / CLS
Requisition ID: 1705616120W
J&J Technology Quality’s Computerized System Validation (CSV) Center of Excellence ensures compliance of systems across the enterprise in accordance with J&J SDLC, assures compliance within the enterprise with applicable global regulations, advise on quality matters, and assist with closing compliance gaps related to audits and inspections.
The Manager, Technology Quality – CSV ERP/CLS/WMS is responsible for guiding and managing the team throughout the implementation of all the components in the Validation Lifecycle for program/projects/system support and other processes/support functions within the organization.
• The role is responsible for planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications in accordance with regulations, and defined company’s quality standards and policies.
• This position will support internal and external Health Authority regulatory audits.
• The position will be responsible for the approval of SDLC validation documentation deliverables w.r.t a region including the approval to release system implementation and/or changes for production use, will attend Project Team meetings and provide CSV compliance guidance and support to project and base business support team members
- A Bachelor’s degree in Computer Science, Information Systems, Business Administration or other related field required; advanced degree preferred; solid, relevant experience may be substituted when appropriate; additional certifications a plus
- A minimum of 7-10 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Computerized System Validation activities
- Experience authoring or approving validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is required
- Strong management skills with experience in Computerized System Validation in GxP environments in the pharmaceutical industry required
- Expert project management and organizational skills are required
- Working knowledge of PMO, SDLC, GAMP 5, ITIL frameworks and Global Regulations like Annex 11, SOX, ISO is highly desirable
- Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required
- Experience in Testing Management tools like HPALM
- Validation experience with implementing systems like CAPA, MES, PLM, SAP, LMS, and Change Control is required.
- Superior written and oral communication and excellent Microsoft Office skills required
- Knowledge of Quality Management process and Computerized System Validation principles a plus
- Must have the ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding Quality
Janssen Pharmaceutica N.V. (7555)