Manager, ERP WMS Leader, Technology Quality

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 jnj.comAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: QualityJob Sub Function: Quality AssuranceJob Category:ProfessionalAll Job Posting Locations:Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of AmericaJob Description:We are searching for the best talent for a Manager, ERP WMS Leader, Technology Quality. Purpose: 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 Manager, ERP WMS Leader, Technology Quality is responsible for building and execution of quality into enterprise-wide systems, tools, and services through their end-to-end lifecycle (design, develop, implement, maintain, retire).You will be responsible for:This role must ensure that all J&J quality standards and global regulatory requirements are being metThis 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 feasibleThis 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 scopeThe role provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholdersThis position will support internal audits and Health Authority regulatory inspectionsThis 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 compliance guidance and support to project and base business support team membersThis role will lead globally diverse teams in an inclusive environmentThis role will provide an environment which encourages the company’s CredoThis role serves as a trusted partner across the Technology Quality & Compliance organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level stakeholdersBuilding and Execution of Quality into Applications and Supporting InfrastructureManages the end-to-end quality process and strategies for building and execution of applications across ERP and WMSEnsures/promotes early involvement of TQ&C in the design and development of applications to ensure automated and preventive controls are built inProvides technical direction and operational support to the individual project teamsEnsures continuous improvement is facilitated through feedback received through incidents and problem ticketsIdentifies measures and metrics for the quality of software and feedback mechanisms to ensure continuous improvementEnsures 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 TQ&C’s portfolioParticipates in audits, approves audit non-conformity action plans, and approves closure of internal audit findingsAssists with incident management/CAPA and NC for the systems supportedSupports the building and execution of quality into Strategic Programs across the enterprise where the use of technology supported by TQ&C is involvedContributes to the creation of strategies for the qualification and validation of new and emerging technologiesResponsible for managing portfolio of programs and large-scale initiativesResponsible for managing project intakes, quotes, estimates, and ASOWsEnsures that all Technology Quality related projects go through the Intake processSupports the allocation of resources by accurately communicating availabilityResponsible for managing resources (both internal and external) and ensure availability for ongoing and upcoming initiatives/projectsDefines internal standards and practices to move the organization toward a more proactive risk management posture by utilizing extensive knowledge of current and emerging best practices in quality risk management and quality engineeringManages Project/Department budgets related to CSV resourcesDemonstrates an understanding of many relevant Quality and Compliance Principles and their applicationsUtilizes knowledge of relevant Quality and Compliance areas to recommend existing solutions to the businessPartners with QMS & Enabling Platforms team to execute defined strategies and provides input and feedback on the efficacy of the strategy, including any recommendations for improvementsContributes to the creation of strategies for the qualification and validation of new and emerging technologiesPartners with Acquisitions, Remediation and Divestiture where applications are impacted to ensure risks for JNJ are mitigatedMaintains a relationship with TS on embedding Quality controls into the operational processManages customer feedback (NPS and other feedback) and follow up processTracks and documents quantifiable business results achieved from project work and writes success stories for publication that demonstrate the business value created by TQ&CStakeholder ManagementPartners with stakeholders to assess and implement compliant solutions to meet their business needBuilds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the sameGains alignment on CSV funding and support of the project with the Business Sponsor and/or Investment OwnerFacilitates cross-functional collaboration among key stakeholders when making decisions and developing strategic plansClearly communicates with stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions and when quality standards are not metProvides partnership, insight and direction to cross-functional business leaders and stakeholders regarding TQ&C policies, solutions, and initiativesCapable in external publications, regulatory guidance documents, and industry standards to ensure the quality framework for technology in healthcare business remains current and incorporates industry best practicesParticipates in and influences decision making in Advisory Boards, Change Advisory Boards, Communities of Practice, and other relevant forumsPeople ManagementManages and leads a globally diverse team across geographies, including FTEs and contractors, within a matrixed organizationIdentifies critical skills and capabilities required to ensure the development of a highly skilled, high performance teamProvides quality guidance and support to project and/or base business support teamsUtilizes 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 infrastructureResponsible for the development of direct reports including training and mentoring to meet current and future business needsConducts performance reviews, succession planning, talent reviews and career development for direct reportsProactively monitors processes to ensure team members remain in compliance with standard operating procedures, audit compliance and industry best practicesQualifications/Requirements: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.6-8 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is requiredExperience in running large scale end-to-end Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and/or Change Control is requiredExperience managing and leading global technology programs along with FTEs/consultant teams across multiple geographiesExperience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is requiredLeadership CompetenciesDemonstrated leadership capabilities fostering diversity and inclusionStrong skills in interdependent partnering and influencingAbility to facilitate and communicate key messages and presentations to various cross-functional groups to gain supportInfluence upwards and peers to ensure compliance and regulatory requirements are metMake the complex clear and easily understood by othersMust have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demandsProfessional CompetenciesSuperior written and oral communication skillsMust 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 validationSolutions-oriented, striving for new ways to accomplish goals and pragmatic advising ensuring compliance in a cost-effective and risk-based mannerMust have the ability to work effectively in a highly matrixed team environmentAbility to manage multiple and competing projects is requiredWorks effectively in a virtual team environmentCore Technical CompetenciesSets vision and ensures adoption for how quality will be designed into and maintained within a technology solutionUnderstands data integrity needed throughout the lifecycle of a technology solutionUnderstands 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 4.0Defines strategy for testing according to the risk assessmentExperience in Testing Management tools like qTest and JIRA XrayImplements elements of an effective quality management system to the organization and its technology solutionsAware of cybersecurity and privacy principles and implications for quality and risk management activitiesApplies best practices for security role design and segregation of duties within and across technology solutionsUnderstands how to prepare an organization and business stakeholders for audits and inspectionsAble to apply digitization tools and techniques to automate, simplify, digitize and enhance software development and validation processesUnderstands and applies best practices for architecting effective data solutions and frameworks that enable high quality dataKnowledge of SDLC Quality Management process and Computerized System Validation/Computerized System Assurance principlesThorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is requiredKnowledge of other Global Regulations like EU Annex 11, SOX, HCC, Security & Privacy, ISO is preferredWorking knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirableKnowledge of Software Quality Assurance and Software Quality Engineering is highly desirableKnowledge of the following technologies and methodologies is highly desirable: Agile, SAFe, CI/CD, RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain, Kubernetes, XaaS, SaMDProject management and organizational skills are requiredJohnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource.Required Skills:Preferred Skills:Business Alignment, Coaching, Collaboration, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical CredibilityThe anticipated base pay range for this position is :$102,000.00 - $177,100.00Additional Description for Pay Transparency: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 yearSick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period 10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - Raritan, New Jersey, United States of America; Horsham, Pennsylvania, United States of AmericaType: Full time