Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. With $65 billion in 2011 sales, Johnson & Johnson 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. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.
Johnson & Johnson Customer & Logistics Services (CLS) is a global Supply Chain organization that supports operating units across all of the Johnson & Johnson Family of Companies. CLS strives to deliver an exceptional customer experience through leading critical customer facing-functions such as distribution and transportation. In addition, CLS oversees critical business enablers, including how we gather and manage supply chain master data, safe and secure supply chain practices, product identification standards, and market/channel access capabilities. CLS supports all three sectors of Johnson & Johnson: Medical Device & Diagnostics, Pharmaceutical, and Consumer Products. This team is represented in multiple countries, and continues to grow globally in both visibility and responsibility. The CLS team reports to Johnson & Johnson Supply Chain and partners closely with groups throughout the supply chain organization.
Johnson & Johnson Customer & Logistics Services (CLS) is currently recruiting for a Manager of Quality Computerized System Validation (Q-CSV) Center of Excellence, located in Bridgewater, NJ.
Quality Computerized System Validation (Q-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 Q-CSV 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.
• 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.
• Supports internal and external Health Authority regulatory audits.
• Responsible for the approval of SDLC validation documentation deliverables with respect to 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
Major Duties and 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
• 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 Q-CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within Q-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 Q-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
• 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
• Minimum of Bachelor degree is required; Master degree, additional certification and/or focused degree in Computer Science, Information Systems, Business Administration or other related field are preferred
• Minimum of eight (8) years required of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Computerized System Validation activities
• Minimum of three (3) years’ required experience in people management
• Experience required in authoring or approving validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports
• Strong management skills with experience in Computerized System Validation in GxP environments in the Life Sciences industry (Pharmaceutical, Medical Device, and/or Consumer)
• Expert project management and organizational skills are required with the ability to manage multiple and competing projects
• Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
• Thorough knowledge required of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820
• Working knowledge of other Global Regulations like Annex 11, SOX, and/or ISO are preferred
• Experience required in Testing Management tools like HPALM and in running end-to-end Validation programs
• Excellent Microsoft Office skills required; with experience with CAPA, MES, PLM, SAP, LMS, and/or Change Control systems desirable
• Knowledge of Quality Management process and Computerized System Validation principles a plus
• Strong interdependent partnering and influencing skills 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
• Preferred Knowledge, Skills and Abilities: Certified Software Quality Engineer (CSQE), Certified Quality Engineer (SQE), Certified Quality Auditor (SQA), Project Management Professional (PMP) or similar
• Position will be based in Bridgewater, NJ and requires up to 30% travel, Domestic (US) and International
United States-New Jersey-Bridgewater
Johnson & Johnson Services Inc. (6090)
A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.