Manager, JJ Technology Quality - CSV PLM/Document Management/LMS/Change Control
Johnson & Johnson is recruiting for a Manager, JJ Technology Quality - CSV PLM/Document Management/LMS/Change Control to be located anywhere in the United States.
JJ Technology Quality's (JJTQ) 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.
You, the Manager, JJ Technology Quality CSV PLM/Document Management/LMS/Change Control 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.
You, the Manager, JJ Technology Quality CSV PLM/Document Management/LMS/Change Control will:
- Be 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.
- Support internal and external Health Authority regulatory audits.
- Be responsible for the approval of SDLC validation documentation deliverables 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
- 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
- Develop 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
- Communicate 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
- Utilize knowledge of relevant Quality and Compliance areas to identify business needs and develop value-added solutions for the assigned business area
- Be 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.
- Develop and maintain an effective working partnership with senior management.
- Mentor talent and help them grow in their careers.
- Collaborate with other leaders and staff within JJ Technology Quality group to ensure each function is executed in an efficient manner.
- Ensure timely reports of status, metrics and time sheets as required by the JJTQ organization
- Ensure timely completion of assigned training
- A Bachelor's degree and a minimum of 8 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Computerized System Validation activities is required.
- A degree in Computer Science, Information Systems, Business Administration or other related field required; or an advanced degree is preferred.
- 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 is required
- Expert project management and organizational skills are required.
- Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is preferred.
- Experience overseeing and providing direction to others is preferred.
- Certified Software Quality Engineer (CSQE), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Project Management Professional (PMP) or similar are preferred
- Thorough knowledge of GxP regulations related to CSV, including 21 CFR Part 11 is required.
- Working knowledge of other Global Regulations like Annex 11, SOX, ISO is preferred.
- Experience in Testing Management tools like HPALM is preferred.
- Validation experience with implementing GxP Regulated systems is required (examples include Doc Management, CAPA, PLM, LMS, Complaint Handling and Change Control).
- Superior written and oral communication and excellent Microsoft Office skills are required
- Strong skills in interdependent partnering and influencing are required.
- 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 is required.
- Ability to independently determine and develop approach to solutions and may determine long-term solution is required.
- Ability to manage multiple and competing projects is required.
- This position will be located anywhere in the United states and may require up to 30% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Pennsylvania-West Chester
North America-United States
Johnson & Johnson Services Inc. (6090)
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