Job Function:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America
Job Description:
Technology & Digital Quality (T&DQ) is a comprehensive organization within J&J that focuses on ensuring the highest standards of quality & compliance. It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation Operations and Temperature Control. Additionally, it includes a Transformation Office dedicated to steering strategic imperatives and enhancing the Quality & Compliance organization's strategy through initiatives like Data Strategy, Automated Product Release, and Digitalization of Quality Management Systems. The group further comprises a Data & Digital Strategy function tasked with developing and executing a holistic digital and data strategy to improve quality and compliance, covering areas such as Data Foundations, AI/ML & IoT technologies, Quality & Compliance Innovation, and Digital Assets validation. To facilitate the deployment of these strategic initiatives, the group employs two Deployment Offices for the MedTech and MedTech segments and maintains a global presence through three regional leaders managing operations in Asia Pacific (ASPAC), Europe, Middle East, Africa (EMEA), and the Americas.
Within Technology & Digital Quality, the IM Deployment office drives targeted strategic transformation and quality operations (CSV) initiatives aligned with the Innovative Medicine (IM) segment strategic priorities.
The Lead, Complaints / Adverse Events 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).
- Ensure that all J&J quality standards and global regulatory requirements are met
- Ensure building and execution activities involve early quality involvement in design and development, integrating quality into work products, implementing controls within applications/solutions, and leveraging automation when feasible
- Own the quality approach for systems and hold teams accountable for delivering an end-to-end support model
- Provide technical and procedural expertise/guidance to project teams, aligning with internal and external stakeholders
- Plan, allocate tasks and resources, execute, coordinate, and maintain validation activities for GxP systems/applications
- Support internal audits and Health Authority regulatory inspections
- Approve SDLC validation documentation deliverables, including release of system implementations/changes for production
- Attend project team meetings, offering T&DQ quality and compliance guidance and support
- Collaborate with globally diverse teams in an inclusive environment
- Promote an environment fostering the company’s credo and the value of a diverse workforce
- Serve as a trusted partner across the Technology & Digital Quality organization, fostering strong collaboration skills at the project team level, internally and externally
Major Duties /Approximate Percentage of Time
Tasks/Duties/Responsibilities
70% - Building and Execution of Quality into Infrastructure
- Ensures/promotes early involvement of T&DQ 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
- Ensures that all Quality Operations related projects go through the Intake process
- Provides strategic direction and operational support to the individual project teams
- 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 T&DQ 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 technology quality tasks according to the project plan, 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
- Reviews and 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
- Proactively monitors systems and processes to ensure compliance with standard operating procedures and industry best practices
- Works with 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
20% -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 T&DQ policies, solutions, and initiatives
- Communicates proactively with stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions and highlight the risk when quality standards are not met
10%- 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 T&DQ in project teams
- Works with T&DQ leadership to nurture future leaders and create opportunities to grow
- Mentors talent and helps them grow in their careers
Performs other work-related duties as assigned
100% Total
Other Duties:
• Develop and maintain an effective working partnership with senior management
• Collaborate with other leaders and staff within IM Deployment Office and Quality Operations group to ensure each function is executed in an efficient manner
• Ensure timely reports of status and metrics as required by the IM Deployment Office organization
• Ensure timely completion of assigned training and expense reports
Required Knowledge, Skills and Abilities:
Leadership Competencies
- Demonstrated leadership capabilities fostering diversity and inclusion
- Strong skills in interdependent partnering and influencing `
- Experience managing and leading global technology programs along with FTEs/consultant teams across multiple geographies
- 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
- Gives input 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 HPALM and JIRA Xray
- Implements elements of an effective quality management system to the organization and its technology solution
- 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
Degrees and Years of Experience
- 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+ years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required
- Experience in 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
- Dire
