Lead, Computer System Validation - T&DQ

Johnson & Johnson•Raritan, NJ

8d•Hybrid

About The Position

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.

Requirements

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
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
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
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
Direct experience working in a software development environment using Agile, SAFe, CI/CD or similar is desirable

Nice To Haves

Certified Software Quality Engineer (CSQE), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Project Management Professional (PMP) or similar.

Responsibilities

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
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
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
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

Benefits

Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick 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 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
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year