Johnson & Johnson Careers

Manager, JJ Technology Quality - CSV Manufacturing/Laboratory Services

Shanghai, China
R&D


Job Description

Requisition ID: 1805620359W

Major Duties/Responsibilities

·        Provide CSV compliance guidance and support to the project teams to ensure successful delivery of the project end to end

·        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

·        Manage teams of internal and external resources and supports the allocation of resources by accurately communicating availability

·        Communicates messages and presentations to various, cross-functional groups to gain support for strategic initiatives and ideas

·        Communicate proactively with stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions and highlight the risk when quality standards are not met

·        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.


Qualifications

·        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

·        Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required

·        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   

Primary Location
China-Shanghai-Shanghai
Organization
Johnson & Johnson Medical China (7052)
Job Function
R&D
Requisition ID
1805620359W