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.com .

As 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:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

São Paulo, Brazil

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