Analyst, Cloud Services - Technology Quality

Johnson & Johnson is recruiting for an Analyst, Cloud Services - Technology Quality located in Raritan, NJ but can be considered for other J&J locations globally. This position may require up to 30% travel (domestic & international).

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.

With $82.1 billion in 2019 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 markets. 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.

 If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections.

The Analyst, Systems & Infrastructure Assurance – Cloud Services – Computerized System Validation, Technology Quality is responsible for guiding and managing the team throughout the building and execution of quality into enterprise wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire).

 

Key Responsibilities:

• This role must ensure that all J&J quality standards and global regulatory requirements are being met
• This role ensures that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible
• This individual will promote the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope
• The role provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders
• The role is responsible for planning, executing and maintaining the validation activities for GxP systems/applications 
• This position will support internal audits and Health Authority regulatory inspections
• This position will 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 TQ&C quality and compliance guidance and support to project and base business support team members
• This role will work with globally diverse teams in an inclusive environment
• This role will promote an environment which encourages the company’s credo and the value of a diverse workforce
• This role serves as a trusted partner across the Technology Quality & Compliance organization, requiring strong collaboration skills at the project team level

Building and Execution of Quality into Applications and Supporting Infrastructure

• Ensures/promotes early involvement of TQ&C in the design and development of applications and infrastructure to ensure automated and preventive controls are built in
• Owns and manages the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure
• Facilitates education and training to the organization on TQ&C program, procedures and controls
• Contributes to the creation of strategies for the qualification and validation of new and emerging technologies
• Provides compliance guidance and support to the project teams to ensure successful delivery of the project end-to-end
• Ensures a high degree of inspection readiness in support of health authority inspections, audits (internal and external) and periodic review of applications and infrastructure in scope of the TQ&C portfolio Participates in audits, approves audit non-conformity action plans, and approves closure of internal audit findings
• Assists with incident management/CAPA and NC for the systems supported
• Manages the execution of TQ tasks according to the project plan, goals and timelines
• Supports the allocation of resources by accurately communicating availability
• Responsible for managing resources (outside services) and ensure availability for ongoing and upcoming initiatives/projects
• Works with various SMEs to obtain needed information to complete validation deliverables
• Authors, reviews and/or approves validation deliverables, such as but not limited to Compliance Plans, User Requirements/User Stories, System Tests, User Acceptance Tests, Traceability Matrices, and Compliance Reports including final release and approval for production use
• Leads testing efforts by managing pre/post approvals and associated discrepancies
• Performs TQ&C reviews and approval of Computerized System change controls
• Proactively monitors systems and processes to ensure compliance with standard operating procedures and industry best practices
• Works with the TQ Manager in developing, monitoring, and managing project costs, schedules, resources and quality of work product
• Assists or drives status meetings to communicate and address project risks or issues
• Works collaboratively with project teams to keep them informed of project status, including any barriers

Stakeholder Management

• Partners with project teams to assess and implement compliant solutions to meet their business needs
• Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same
• Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding TQ&C policies, solutions, and initiatives
• Communicates proactively with stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions and highlights the risk when quality standards are not met

People Management

• Provides quality guidance and support to project and/or base business support teams
• Utilizes expert knowledge regarding risk management practices and leads and mentors the team with critical thinking and risk-based approaches to carry out validation of computerized systems and infrastructure
• Responsible for the management of consultants and outside service providers assigned to support TQ in project teams
• Works with TQ&C leadership and pillar leaders to nurture future leaders and create opportunities to grow
• Mentors talent and helps them grow in their careers

Other Duties & Responsibilities

• Develop and maintain an effective working partnership with senior management
• Collaborate with other leaders and staff within Technology Quality and Compliance group to ensure each function is executed in an efficient manner
• Ensure adherence to the TQ&C Operating Model
• Ensure timely reports of status, metrics and time sheets as required by the Technology Quality and Compliance organization
• Ensure timely completion of assigned training and expense reports

Qualifications

Qualifications

• A Bachelor’s degree in Computer Science, Information Systems, Business Administration or another related field required. Solid, relevant experience may be substituted when appropriate, additional certifications a plus
• At least 2 years of relevant experience to the role is required
• Experience in System design, deployment and validation/qualification is preferred
• Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is preferred
• Proficiency using the following tools is highly desirable: JIRA, HPALM, Xray, Jenkins, Selenium,
• Direct experience working in a software development environment using Agile, SAFe, CI/CD or similar is a plus
• Strong organizational and technical writing skills required
• Understands data integrity needed throughout the lifecycle of a technology solution
• Understands traditional and emerging methods and theory of quality, including, but not limited to TQM principles, Continuous Improvement, Cost of Quality, Quality 4.0 and Industry 4.0
• Knowledge of Testing Management tools like HPALM and JIRA Xray
• Aware of cybersecurity and privacy principles and implications for quality and risk management activities
• Understands how to prepare an organization and business stakeholders for audits and inspections
• Able to apply digitization tools and techniques to automate, simplify, digitize and enhance software development and validation processes
• Knowledge of SDLC Quality Management process and Computerized System Validation/Computerized System Assurance principles
• Experience working in a regulated environment with high emphasis on Validation/Qualification & Compliance of systems and processes is a plus
• 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 EU Annex 11, SOX, HCC, Security & Privacy, ISO is preferred
• Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
• Knowledge of Software Quality Assurance and Software Quality Engineering is highly desirable
• Knowledge of the following technologies and methodologies highly desirable: RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain, Kubernetes, XaaS, SaMD.
• Project management and organizational skills are desired
• 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 and validation
• Solutions oriented, striving for new ways to accomplish goals and pragmatic advising ensuring compliance in a cost-effective and risk-based manner
• Must have the ability to work effectively in a highly matrixed team environment
• Ability to manage multiple and competing projects is required
• Works effectively in a virtual team environment

 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-New Jersey-Raritan-1003 US HIghway 202
Other Locations
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Organization
Johnson & Johnson Services Inc. (6090)
Job Function
Quality
Requisition ID
2105893796W

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