Lead, Complaints / Adverse Events (CSV)

Johnson & Johnson • Raritan, NJ

4d • Hybrid

About The Position

Enterprise Quality 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. Enterprise Quality (EQ) drives targeted strategic transformation and quality operations (CSV) initiatives aligned with the Innovative Medicine (IM) and MedTech (MT) 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 EQ 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 Enterprise Quality organization, fostering strong collaboration skills at the project team level, internally and externally.

Requirements

• BS or Equivalent Experience
• 6+ years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required
• 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
• 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
• 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
• 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

Nice To Haves

• 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.
• 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, Qtest, Xray, Jenkins, Selenium
• Direct experience working in a software development environment using Agile, SAFe, CI/CD or similar is desirable

Responsibilities

• Ensures/promotes early involvement of EQ 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 EQ 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 EQ 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 EQ in project teams
• Works with EQ 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 Enterprise Quality to ensure each function is executed in an efficient manner
• Ensure timely reports of status and metrics as required by the Enterprise Quality organization
• Ensure timely completion of assigned training and expense reports

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior