Johnson & Johnson Careers
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Manager, JJ Technology Quality - CSV Manufacturing/Laboratory Services
Requisition ID: 1805620359W
· Participate in audits, approves audit non-conformity action plans and approve closure of internal audit findings
· Perform review and approval of validation test scripts including test defects Review/approval of validation documentation deliverables such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrix, and the Compliance Report including final release and approval for production use
· Develops and communicate compelling, fact-based rationales that contain strong, logical arguments that build support for one’s perspectives and initiatives cross-functionally, and helps others to do the same
· Ensure a high degree of Inspection Readiness for Systems in CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibility
· Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
· Manage the end to end project execution from inception till completion by monitoring CSV tasks according to the project plan, goals and timelines.
· Perform Project tracking and management reporting and manage quality expectation on the project deliverables
· Communicates messages and presentations to various, cross-functional groups to gain support for strategic initiatives and ideas
· Utilizes knowledge of relevant Quality and Compliance areas to identify business needs and develop value-added solutions for the assigned business area
· Responsible for the development of direct reports by supporting the development of Human Resources Planning (HRP) programs including management development and training to meet current and future business needs.
· Provide an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force.
· 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, and ITIL frameworks is highly desirable
· Working knowledge of other Global Regulations like Annex 11, SOX, ISO is preferred
· Experience in Testing Management tools like HPALM
· Experience in running end-to-end Validation programs supporting the area is required. Experience with CAPA, MES, PLM, SAP, LMS, and Change Control systems is desirable
· Superior written and oral communication and excellent Microsoft Office skills required
· Knowledge of Quality Management process and Computerized System Validation principles a plus
· Strong skills in interdependent partnering and influencing required
· 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
· Must have the ability to independently determine and develop approach to solutions and may determine long-term solution
· Ability to manage multiple and competing projects is required.Fluent in English and at least one of the languages spoken in the region where position is located
Johnson & Johnson Medical China (7052)