At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Digital Quality **Job Category:** Professional **All Job Posting Locations:** Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America **Job Description:** Johnson & Johnson is currently recruiting a **Manager, Data & Platforms** ! This position can be located in Horsham, PA or Raritan, NJ. **Position Summary:** Enterprise Quality manages the Quality and Compliance strategy for IT systems including Data Platforms, infrastructure and automation solutions for J&J. EQ 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 Leader of Data and Platforms, Enterprise 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). + 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 own 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, task and resource allocations, executing, coordinating 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 quality and compliance guidance and support to project and base business support team members + This role will lead globally diverse teams in an inclusive environment + This role will provide an environment which encourages the company’s credo and the value of a diverse workforce. This role serves as a trusted partner across the Enterprise Quality organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level stakeholders **Key Responsibilities:** _Building and Execution of Quality into Data Platforms and Supporting Infrastructure (65%)_ + 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 + Manages the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure + Ensures that all Technology Quality related projects go through the Intake process + Provides strategic direction and operational support to the individual project teams + Supports the building and execution of quality into Strategic Programs across the enterprise where the use of technology supported by TQ is involved + Contributes to the creation of strategies for the qualification and validation of new and emerging technologies including AI/ML + Keep up to date with the latest advancements in AI/ML technology and its regulatory requirements and apply them to improve the company's offerings and compliance posture + 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 reviews 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 project plans, goals and timelines + Supports the allocation of resources by accurately communicating availability + Responsible for managing resources (both internal and external) and ensuring availability for ongoing and upcoming initiatives/projects + Performs reviews and approval of 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 + Proactively monitors systems and processes to ensure compliance with standard operating procedures and industry’s best practices + Tracks and documents quantifiable business results achieved from project work and writes success stories for publication that demonstrate the business value created by TQ&C + Manages Project budgets _Stakeholder Management (20%)_ + Partners with stakeholders to assess and implement compliant solutions to meet their business need + Builds and maintain trust, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same + Gains alignment on funding and support of the project with the Business Sponsor and/or Investment Owner + 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 highlight the risks when quality standards are not met _People Management (15%)_ + Manages and leads a globally diverse team across geographies, including FTEs and contractors, within a matrixed organization + Identifies critical skills and capabilities required to ensure the development of a highly skilled, high-performance team + 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 development of direct/indirect reports including training and mentoring to meet current and future business needs + Works with TQ&C leadership and pillar leaders to nurture future leaders and create opportunities to grow + 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 + Conducts performance reviews, succession planning, talent reviews and career development for direct reports + Performs other work-related duties as assigned _Other Duties:_ + Develop and maintain an effective working partnership with senior management + Collaborate with other leaders and staff within Enterprise Quality group to ensure each function is executed in an efficient manner + Ensure adherence to the EQ Operating Model + Ensure timely reports of status, metrics and time sheets as required by the Enterprise Quality organization + Ensure timely completion of assigned training and expense reports **Qualifications:** **Education:** A minimum of a Bachelors or equivalent University degree is required with a focus Computer Science, Information Systems, Business Administration or another related field preferred. **Required Skills, Knowledge & Capabilities:** + 8-10 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required + Experience in running large scale end-to-end Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and Change Control is preferred + Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required + Proficiency using the following tools is highly desirable: JIRA, HPALM, Xray, Jenkins, Selenium + Experience managing and leading global technology programs along with FTEs/consultant teams across multiple geographies + Direct experience working in a software development environment using Agile, SAFe, CI/CD is highly desirable **Core Technical Competencies** + Sets vision and ensures adoption for how quality will be designed into and maintained within a technology solution + Understands data integrity needed throughout the lifecycle of a technology solution + Experience with validation of AI/ML and Intelligent Automation including RPA. Associated skill sets should include platforms GenAI, AWS/Microsoft related cloud services, data modeling, model training, deep learning and controls with validation strategy + 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 + Defines strategy for testing according to the risk assessment + Experience in Testing Management tools like HPALM, JIRA with Xray, Selenium + Implement elements of an effective quality management system to the organization and its technology solutions + Aware of cybersecurity and privacy principles and implications for quality and risk management activities + Applies best practices for security role design and segregation of duties within and across technology solutions + 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 + Understands and applies best practices for architecting effective data solutions and frameworks that enable high quality data + Knowledge of SDLC Quality Management process and Computerized System Validation/Computerized System Assurance + principles + 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: Agile, SAFe, CI/CD, RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain, Kubernetes, XaaS, SaMD + Project management and organizational skills are required Other: This position may require up to 15% domestic travel. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. 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. **The anticipated base pay range for this position is :** $100,000- $173,500  USD$ Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits