Job Function: Quality
Job Sub Function: Quality Assurance
Job Category:Professional
All Job Posting Locations:Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America
Job 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 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
- 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 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
- This 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 stakeholders
Building and Execution of Quality into Applications and Supporting Infrastructure- Manages the end-to-end quality process and strategies for building and execution of applications across ERP and WMS
- Ensures/promotes early involvement of TQ&C in the design and development of applications to ensure automated and preventive controls are built in
- Provides technical direction and operational support to the individual project teams
- Ensures continuous improvement is facilitated through feedback received through incidents and problem tickets
- Identifies measures and metrics for the quality of software and feedback mechanisms to ensure continuous improvement
- 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 TQ&C's 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
- Supports the building and execution of quality into Strategic Programs across the enterprise where the use of technology supported by TQ&C is involved
- Contributes to the creation of strategies for the qualification and validation of new and emerging technologies
- Responsible for managing portfolio of programs and large-scale initiatives
- Responsible for managing project intakes, quotes, estimates, and ASOWs
- Ensures that all Technology Quality related projects go through the Intake process
- Supports the allocation of resources by accurately communicating availability
- Responsible for managing resources (both internal and external) and ensure availability for ongoing and upcoming initiatives/projects
- Defines 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 engineering
- Manages Project/Department budgets related to CSV resources
- Demonstrates an understanding of many relevant Quality and Compliance Principles and their applications
- Utilizes knowledge of relevant Quality and Compliance areas to recommend existing solutions to the business
- Partners with QMS & Enabling Platforms team to execute defined strategies and provides input and feedback on the efficacy of the strategy, including any recommendations for improvements
- Contributes to the creation of strategies for the qualification and validation of new and emerging technologies
- Partners with Acquisitions, Remediation and Divestiture where applications are impacted to ensure risks for JNJ are mitigated
- Maintains a relationship with TS on embedding Quality controls into the operational process
- Manages customer feedback (NPS and other feedback) and follow up process
- 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
Stakeholder Management- Partners with stakeholders to assess and implement compliant solutions to meet their business need
- 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
- Gains alignment on CSV funding and support of the project with the Business Sponsor and/or Investment Owner
- Facilitates cross-functional collaboration among key stakeholders when making decisions and developing strategic plans
- Clearly communicates with stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions and when quality standards are not met
- Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding TQ&C policies, solutions, and initiatives
- Capable 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 practices
- Participates in and influences decision making in Advisory Boards, Change Advisory Boards, Communities of Practice, and other relevant forums
People Management- 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 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 reports including training and mentoring to meet current and future business needs
- Conducts performance reviews, succession planning, talent reviews and career development for direct reports
- Proactively monitors processes to ensure team members remain in compliance with standard operating procedures, audit compliance and industry best practices
Qualifications/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 required
- Experience in running large scale end-to-end Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and/or Change Control is required
- Experience managing and leading global technology programs along with FTEs/consultant teams across multiple geographies
- Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required
Leadership Competencies- Demonstrated leadership capabilities fostering diversity and inclusion
- Strong skills in interdependent partnering and influencing
- Ability to facilitate and communicate key messages and presentations to various cross-functional groups to gain support
- Influence upwards and peers to ensure compliance and regulatory requirements are met
- Make the complex clear and easily understood by others
- Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands
Professional Competencies- Superior written and oral communication skills
- 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
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
- 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 qTest and JIRA Xray
- Implements 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
- 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 is 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
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 Credibility
The anticipated base pa 
