Johnson & Johnson

QA Engineer

• Quality point of contact for cell and gene laboratories at Leiden and their contract laboratories.
• Acts as Quality Subject Matter Expert (SME) for assigned quality processes and/or analytical techniques ensuring an appropriate quality and compliance level by applying risk management in line with the intended use and phase of development.
• Establish and develop cooperative working relationships within and across the cell and gene laboratories, CSQ, global quality organization, including single quality voice in the analytical area.
• Review and approval of laboratory related documents such as validation/transfer/ investigation protocols and reports, procedures and work instructions.
• Handle quality issues, CAPAs, and change controls that are initiated by our business partners and/or their contractors and contract laboratories.
• Ensure that Quality and Compliance operational targets are met.
• Support quality oversight via periodic quality reviews e.g. internal audits, quality metrics, round tours.
• Report Quality trends and makes a positive contribution via ideas for improvement.
• Involvement in implementation of new insights, process improvements and departmental strategic discussions.
• Support and act as spokesperson during Health Authority inspections and customer audits.

QA Associate

Manager

• Execute study-level activities, create and update trial-specific documents
• Vendor oversight & delivery
• Country and regional oversight of local operational delivery
• Align feasibility strategy and target setting
• Perform country-level risk reviews
• Resolve trial-related issues
• Mentor & support onboarding of new team members

Manager, Trial Delivery

Marketing

• Develop Ischemic business strategy for EMEA to retain and grow market position.
• End-to-end product management of Ischemic product portfolio.
• Deliver financial commitments for the Ischemic product platforms.
• Lead the implementation of world-class new product launches within EMEA for Ischemic portfolio, ensuring strategic alignment and a rigorous application of Launch Excellences processes and metrics to achieve sales and share growth targets.
• Develop effective relationships with KOL’s and local leaders, marketers and key customers within priority markets to drive execution of EMEA Ischemic portfolio strategy.
• Lead NV EMEA Ischemic S&OP processes in partnership with Supply Chain to ensure accurate forecasting and demand planning.

Neurovascular Ischemic Marketing Manager

Software Engineer

• Completes programming trial activities of low complexity and/or criticality, with high quality and timeliness of deliverables.
• Designs and develops programs in support of clinical analysis and reporting activities.
• May support submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages.
• Performs activities in accordance with departmental processes and procedures.
• Performs appropriate quality control and verification in support of clinical analyses and reporting activities.
• Performs review and provides feedback on project requirements and documentation.
• Collaborates effectively with team and cross-functional members.
• Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position.
• May contribute to departmental innovation and process improvement projects.
• Reviews specifications for mapping internal Data Review Model (DRM) for fit-for-purpose reporting consumption and ensures verification of DRM.
• Supports data cleaning by programming edit checks and data review listings and data reporting by creating data visualizations and listings for data management, medical monitoring, and central monitoring.

Associate Clinical Programmer

• Provide quality oversight for computer system validation activities in accordance with Janssen policies
• Act as Process Owner for Computer Systems Validation management
• Review and approve CSV documents such as SOPs, user requirements, risks analyses, Validation Plans, tests, changes, deviations
• Maintain a current knowledge of international laws, guidelines related to CSV
• Prepare for computer system audits and inspections
• Cooperate with engineering, IT and other teams for the introduction of new systems and processes

Business Operations

• Project management: You will work closely with SBO directors and Sr directors to oversee various initiatives within R&D, ensuring that they are executed successfully and within the given timelines.
• Operations Strategy: You will play a key role in developing and implementing strategic plans to optimize the business operations.
• Stakeholder Management: You will interact with various stakeholders, both internal and external to R&D, to ensure alignment and collaboration across the organization.
• Continuous Improvement: You will constantly seek opportunities for process improvement and innovation within R&D operations.
• Communication: Encourage open communication and collaboration among team members.
• People leadership: Ability to inspire, guide, and positively influence individuals and teams towards achieving common goals.

Associate Director, Project Management, Business Operations

Data Scientist

• Support the Chief Data Science Officer and Senior Director in executing near- and long-term data science strategies.
• Design and implement appropriate governance for the Integrated IT roadmap for R&D.
• Partner across the DSDH Strategy and Operations team to ensure flawless execution of Portfolio and Project Management tasks, initiatives and strategies.
• Lead cross-functional teams to deliver on key initiatives, ensuring collaboration and alignment with internal and external partners.
• Provide strategic input and operational expertise, including use business case quantification and value articulation.
• Oversee the Data Science project portfolio, ensuring prioritization, resource allocation, and timely delivery of projects.
• Implement and optimize project management processes and best practices, including using Wrike.
• Develop and maintain dashboards and reporting tools to track project status, risks, and outcomes.
• Lead, mentor, and develop a team of matrixed project managers, fostering a high-performance culture.
• Drive change management and continuous improvement initiatives within the team and across the organization.
• Partner with Finance and HR to manage budgets, headcount, and resource planning for the Data Science organization and Integrated IT Roadmap.
• Consolidate input from therapeutic and functional areas to ensure consistent financial planning and governance.
• Serve as a key liaison between Data Science, Therapeutic Areas, IT and other enabling functions.
• Communicate DSDH and Integrated R&D IT project and/or portfolio progress to senior leadership and stakeholders.

Director, Data Science Strategy – Operations

Director

• Provide strategic leadership for the Bi-Car / Next-Gen cell therapy program from a Quality perspective, ensuring alignment with overall business goals, product pipeline needs, and long-term enterprise objectives.
• Co-develop, with Operations and cross-functional technical functions, the comprehensive E2E quality strategy for automated and robotic manufacturing and QC testing platforms.
• Establish the long-range vision and roadmap for manufacturing and QC innovation, scalability, and technology advancement in close partnership with R&D and Pilot Plant investments.
• Serve as primary Quality accountable for the end-to-end program lifecycle—from feasibility through full-scale commercial operations.
• Collaborates with site leaders and cross-functional global teams to optimize supply chain access, expand manufacturing capacity, and ensure timely delivery of high-quality products globally.
• Lead the Quality review & approval for the design, build, and startup of two (2) state-of-the-art next-generation cell therapy facilities, in US and EU .
• Ensure all required quality systems, technologies, and digital platforms are development-ready and integrated for commercial deployment.
• Identify, manage, and mitigate program risks; establish and track KPIs to ensure transparency, performance, and timely achievement of investment key event milestones.
• Partner closely with Manufacturing, R&D, Supply Chain, Regulatory, and Commercial to align on dependencies, address cross-functional issues, and ensure smooth progression from clinical to commercial operations.

Senior Director, Next Gen CAR-T Quality Leader

Engineer

• Collaborate with cross-functional teams to optimize network performance and ensure the highest standards of quality and compliance.
• Implement standard processes for supply chain management, logistics, and distribution to enhance operational effectiveness.
• Identify and Lead to process improvements projects, including new materials or technologies to deliver innovations and increase the reliability of our processes and plants.
• Develop and monitor key performance indicators (KPIs) to track operational performance and identify areas for improvement.
• Work closely with the production and manufacturing teams to optimize resource utilization and reduce costs.
• Drive organizational change by implementing effective change management strategies and communication plans.
• Identify potential risks and develop mitigation strategies to minimize disruption to operations.
• Assess and implement local changes based on global initiatives/product strategy.
• Understand operational network differences and enable efficiencies across the network, where appropriate.
• Continuously monitor/analyze manufacturing performance and design projects/initiatives to enable manufacturing performance, cost reduction, and process robustness objectives
• Support the creation of business cases for ongoing improvement projects, including risk management, financial analyses, and regulatory compliance assurance.

Senior Material Excellence Engineer, LCM

• Collaborate with cross-functional teams to optimize network performance and ensure the highest standards of quality and compliance.
• Implement standard processes for supply chain management, logistics, and distribution to enhance operational effectiveness.
• Identify and Lead to process improvements projects, including new materials or technologies to deliver innovations and increase the reliability of our processes and plants.
• Develop and monitor key performance indicators (KPIs) to track operational performance and identify areas for improvement.
• Work closely with the production and manufacturing teams to optimize resource utilization and reduce costs.
• Drive organizational change by implementing effective change management strategies and communication plans.
• Identify potential risks and develop mitigation strategies to minimize disruption to operations.
• Assess and implement local changes based on global initiatives/product strategy.
• Understand operational network differences and enable efficiencies across the network, where appropriate.
• Continuously monitor/analyze manufacturing performance and design projects/initiatives to enable manufacturing performance, cost reduction, and process robustness objectives.
• Support the creation of business cases for ongoing improvement projects, including risk management, financial analyses, and regulatory compliance assurance.

Senior Material Excellence Engineer – LCM

• Collaborate closely with cross functional partners to support an integrated approach to site engagement, driving cohesion and maximizing effectiveness
• Collaborate with the IHE&A innovation team to implement decentralized clinical trial (DCT) elements into scalable solutions for our study teams
• Site insights management – support generation of insights (includes management of site advisory networks & survey governance), build processes, and support insight integration into different internal workflows
• Support the development of tailored engagement approaches and tools for priority markets to optimize effectiveness
• Lead and support the improvement of ways of working to streamline experience for our sites through cross-functional collaboration, initiative and project leadership
• Work collaboratively with DUs and GCO countries to understand their needs in site engagement, in support of the global JJIM R&D portfolio
• Adopt a client service mindset to ensure an integrated approach to engagement across IHE&A

Associate Director – Site Engagement Strategy

Chief Technology Officer

• The Senior Director, Head of Technology – Discovery, will be responsible for the overall technology strategy, project management, and application support & development for the Therapeutics Discovery (TD) & Preclinical Sciences & Translational Safety (PSTS) business functions of Johnson and Johnson Innovative Medicines.
• This is a critical leadership role in the Research Systems organization, supporting Discovery and Early Development, an organization that exists to enable a next-generation R&D ecosystem that is highly automated, software-defined, data-centric and AI-augmented.
• Partnering with scientific functions, this role will lead and contribute to matrixed teams alongside Data Science & Digital Health and cross-functional technology partners: Engineering, Laboratory Systems, Enterprise Architecture, Information Security & Risk, and Technology Services.
• Report on the progress of workstreams/capabilities within scope of responsibility.
• Develop a future roadmap for systems or capability areas within areas of responsibility and ensure the technical approaches and capabilities solutions are in-line with technical/business strategy.
• Complete understanding and experience working within and leading an Agile development team.
• Accountable for the day-to-day operation of Discovery Systems. In partnership with Suppliers and Technology Services, ensuring that all tickets are resolved within SLA and change management processes are followed as defined in change management procedure and platformed is patched and upgraded to supported level.

Head of Technology – Discovery

• Responsible for the overall technology strategy, project management, and application support & development for the Therapeutic Development and [Clinical] Supply business function.
• Lead a team of about 5-8 direct reports along with 15 - 20 indirect employees and contractors.
• Report on the progress of workstreams/capabilities within scope of responsibility.
• Develop a future roadmap for systems or capability areas within areas of responsibility and ensure the technical approaches and capabilities solutions are in-line with technical/business strategy.
• Complete understanding and experience working within and leading an Agile development team.
• Accountable for the day-to-day operation of Therapeutic Development and Supply Systems.
• Provide evaluation and cost estimation for all projects, enhancements and roll outs.
• Understand core internal IT products and drive business value by working with Suppliers like: Biovia, Revvity, Benchling, PAS-X, NGENCODAC, OMP, IVRS and other vendors.

Head of Technology – Early Development

Administrative Assistant

• Provide administrative support to at least two (2) senior directors/directors within the Johnson & Johnson North America Innovative Medicine
• Be the public face of the directors you support, and represent them, our IM US Operations Department, and the Company professionally and effectively in all interactions
• Be fully aware of and current with the supervisors’ responsibilities
• Communicate effectively with internal and external partners at all levels, including on confidential and critical matters
• Perform administrative tasks for directors, as requested
• Calendar Administration: proactively and thoughtfully manage directors’ calendars and contacts in MS Outlook; schedule business-related meetings/conferences including web-based or Global Connect, Zoom, Microsoft Teams; coordinate availability with attendees; reserve conference rooms; verify and arrange for needed A/V equipment; organize food/catering arrangements; and proactively resolve meeting conflicts
• Travel Coordination: organize thoughtful and efficient business-related domestic and international travel and manage logistics of travel-related activities (flight, hotel and transportation)—including application for travel visas
• Business Expense Reporting: collect receipts, enter expenses into expense reporting system (Concur) and maintain documentation for submitted expenses in compliance with J&J company policies
• Procurement: Assist with preparation of agreements and contracts with outside consultants and vendors, submit purchase orders and/or check requisitions (Health Care Compliance GO-EX, International Contracts Database, eMarketplace) in compliance with J&J company policies
• Answer phones, direct inquiries and ensure back-up coverage for the directors you support, when needed
• Deliver an excellent visiting experience to visitors
• Document Preparation & Maintenance: Draft memorandums, correspondence, and/or presentations as needed
• Take notes and distribute post team meetings
• Critically review and proofread documents
• Appropriately handle documents and matters of a highly confidential nature with discretion
• Coordinate electronic file management of documents to ensure version control and organization of files (Microsoft Teams, SharePoint)
• Maintain Client Relationship Manager (CRM) updates for leaders
• Demonstrate flexibility and the ability to independently manage and respond to multiple priorities and shifting demands while maintaining the sense of urgency and intensity that the office requires
• Proven ability to communicate effectively and articulately with all levels of the organization
• Think analytically, exercise sound judgment and discretion
• Assemble relevant data, compile statistics or information as directed
• Project Management: Track deliverables, due dates and ensure follow-up as needed on projects and assignments
• Master use of all technology associated with your support of the leaders’ roles
• Able to handle a workload that may involve critical deadlines
• Demonstrate strong attention to detail and follow-through on all assigned tasks
• Build and maintain effective relationships and trusted partnerships with internal and external stakeholders
• Develop in-depth knowledge of department objectives, policies and procedures
• Acquire knowledge of department organizational structure
• Collaborate with administrative staff colleagues in the Washington, DC office to ensure office efficiencies
• Work on special projects, as needed

Senior Administrative Assistant

Financial Planning and Analysis

• As a trusted finance partner, you will take charge of end-to-end finance support for multiple Ottava teams, encompassing: Period Close Activities: Ensure timely and accurate financial closure.
• Budget Forecasting: Drive financial forecasts and Budget Planning.
• Financial Submissions: Collaborate with the FP&A consolidation team for essential financial submissions.
• Performance Analysis: Provide insights through monthly Budget vs. Actual (BVA) reviews, tracking risks and opportunities.
• Cross-Functional Liaison: Act as a bridge between business unit partners and teams in procurement, supply chain, legal, and HR to ensure seamless collaboration.
• Transaction Processing: Work with shared services to process transactions efficiently, including intercompany transactions and Global Services requests.
• Management Insight: Support the preparation of Management Review Decks and provide ad hoc project support for operational improvement initiatives and strategic projects.