Johnson & Johnson

Therapist

• Serve as the technical compliance authority for CAR‑T GMP processes and controls across the global network
• Define and lead a global CAR‑T compliance strategy, aligned to IM Compliance objectives and IMQ priorities
• Establish and maintain minimum compliance and technical standards for CAR‑T critical activities
• Maintain continuous inspection readiness across all internal and external partners
• Lead inspection strategy, mock inspections, readiness assessments, and executive briefings
• Act as primary or co-lead in interactions with regulatory authorities (FDA, EMA, MHRA, PMDA)
• Design and lead a risk-based audit program across the CAR‑T ecosystem
• Oversee CAPA effectiveness verification and trend analysis to prevent recurrence
• Lead proactive identification and prioritization of GMP risks across CAR‑T operations
• Ensure robust governance over deviations and investigations, root-cause analysis quality, and CAPA design and effectiveness
• Act as a cross-functional integrator, ensuring alignment across IM: Compliance Quality Manufacturing Supply Chain Clinical Operations Regulatory Affairs
• Build and lead a high-performing, technically strong compliance team

Senior Director, CAR T GMP Compliance – Advanced Therapy Platform

Compliance

• Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned.
• Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic area.
• Assist in the preparation of meetings and act as backup for contact with Regulatory Agencies as needed.
• Ensure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategy.
• Work cross-functionally, interact with internal and external colleagues with coordination between departments, and lead team meetings as appropriate.
• Advise team in required documents and submission strategies.
• Review clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirements.
• Support the development and improvement of processes related to regulatory submissions.
• Provide regulatory input for and follow-up to inspections, audits, litigation support, and product complaints.
• Stay on top of current and pending approvals in assigned therapeutic areas and is knowledgeable of laws, guidelines and requirements related to those areas.
• May interact with Health Authorities (HA) regarding program-specific issues and serve as secondary HA point-of-contact to represent J&J/Janssen externally with some degree of supervision.

Senior Regulatory Affairs Professional

Operations

• drive and shape digital laboratory processes across global QC Operations
• ensure high-quality data eLIMS configurations for efficient laboratory workflows
• integrate laboratory instruments and applications into the eLIMS system
• review and test system updates, create and maintain system documentation
• develop a deep understanding of site-specific laboratory processes
• mentor, coach, and train colleagues in the team

Technical Expert, eLIMS, QC Operations

Manager

• Educate HCPs on product coverage, prior authorizations and appeals, reimbursement processes, claims submissions, procedures, and coding requirements of payer organizations (local payers, government payers, etc.) for core and launch products.
• Collaborate with field support team members such as sales representatives and key account managers and serve as reimbursement expert for the local team.
• Act with a sense of urgency to address critical access and affordability issues for patients.
• Partner with managed care colleagues to understand current policies and potential future changes.
• Conduct field-based reimbursement and access support, education and creative problem-solving aligned to FRM Rules of Engagement
• Build strong, trust-based relationships with customers in all assigned Immunology accounts.
• Manage territory logistics, routing, and account business planning.
• Maintain and grow knowledge of national, regional, local, and account market dynamics including coverage and coding requirements.
• Grow the knowledge of hub and specialty distribution channels to improve practice and patient support needs.
• Collaborate with internal J&J departments such as marketing, sales, medical science, SCG, IBG, HCC, and PECS.
• Serve as subject matter expert regarding education and insights on access and affordability solutions across multiple payer types and plans (i.e., Medicare, Medicaid Managed Care, Commercial).
• Execute business in accordance with the highest ethical, legal, and compliance standards, including timely and successful completion of all required training.

Field Reimbursement Manager – Immunology, Dermatology

• As the global regulatory lead for assigned projects, develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area
• Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market access plans
• Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization, including providing input on implications of regulatory strategy through participation in product-related teams
• Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed
• Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs)
• Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy
• Lead and oversee key health authority documents (e.g., IND/CTA, meeting requests, briefing packages, responses, marketing applications) according to the strategic plan for the region and health authority commitments
• Perform critical review of submission documents to ensure compliance with regulatory requirements
• Negotiate and manage regional post-approval commitments and global label expansion strategies
• Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams
• Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling, risk management, and development programs to meet global and regional requirements
• Support due diligence and business development assessments
• Identify and resolve regulatory issues that may affect projects or organizational objectives

Director, Global Regulatory Leader

• Provide leadership and strategic direction for U.S. IM R&D PPP initiatives, federal and state; serve as a highly valued resource to U.S.-based IM R&D leaders.
• Act as the primary SPRG point of contact for senior U.S. IM R&D leaders and external U.S. stakeholders, including federal and state agencies and consortia.
• Lead capture strategy, relationship development, and opportunity shaping with U.S. agencies (e.g., NIH, BARDA/ASPR, ARPA-H, DARPA, DoD/CDMRP, DTRA, VA/ORD, CDC, NIST, NSF) and relevant state/regional innovation bodies.
• Oversee end-to-end PPP lifecycle—opportunity identification, internal alignment, proposal development, submission, negotiation, execution, governance, close-out, and audit readiness—ensuring timelines, approvals, and communications are met.
• Navigate and help negotiate complex U.S. mechanisms, including grants, cooperative agreements, CRADAs, OTAs, contracts, prizes/challenges, and research consortia agreements, in alignment with Legal, IP, and Compliance and Grant Experts (within SPRG)
• Ensure adherence to U.S. federal regulations and policies applicable to PPPs (e.g., Uniform Guidance 2 CFR Part 200, Bayh–Dole Act obligations for IP, and FAR/DFARS where applicable).
• Conduct advanced analyses of U.S. R&D trends, federal appropriations, and agency priorities, and translate insights into a proactive PPP pipeline aligned with IM R&D strategy.
• Foster a highly collaborative culture across Grant Experts, Operations/PMO, Legal, IP, HCC, GA&P, Finance, and Procurement to deliver efficient, high-quality outcomes.
• Maintain high standards of partner service delivery via regular check-ins with senior U.S. R&D leaders; communicate strategically to bring visibility to SPRG initiatives and outcomes.

Senior Manager, Focus Area Leader – IM R&D

Risk

• Works with the trial teams and/or Program teams to coordinate the identification, assessment, and mitigation of quality risks that could impact on trial data integrity, patient safety, well – being, or rights.
• Executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs).
• Ensures compliance with regulatory requirements and internal procedures, and maintains a continued state of inspection readiness.
• Actively participates in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.
• Leads regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction.
• Communicates and facilitates risk updates to R&D colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora.
• Develops and ensures a consistent interpretation of issues that require quality investigations.
• Provides guidance for significant quality issues per corporate standards and escalates significant quality issues to senior R&D management.
• Drives ongoing inspection readiness activities with trial teams to develop inspection narratives and coordinates mock inspection in collaboration with Regulatory Compliance teams.

Manager, Clinical Risk Management

• Develop and execute strategies across the External Manufacturing & Electronic Systems category
• Foster a customer-first culture within the team
• Provide oversight and direction for global EM&S category strategies
• Guide cross functional team in supplier segmentation and relationship management
• Monitor global EM&S market trends, cost drivers
• Deliver on financial targets including savings, cost avoidance, cash flow and value creation

Senior Manager, SCP EM&S Category

Analyst

• Support the global deployment of SAP Quality Management capabilities integrated with NextGen QS, enabling real-time quality event handling and non-conformance management across Source, Make, and Deliver.
• Ensure standard satellite system integrations enabling end-to-end release management, laboratory testing, manufacturing batch record review, and artwork (packaging material) key date governance.
• Enable Global Batch Traceability through a single ERP backbone after full deployment and prepare the solution for future GBT and BRH integration.
• Define and govern batch determination rulesets ensuring compliant batch usage for internal operations and customer shipment.
• Work under guidance of Quality Management functional SMEs and analysts, owning workload planning, prioritization, and delivery quality.
• Provide functional leadership and coaching while remaining hands-on to ensure solution quality and regulatory compliance.
• Collaborate with Manufacturing, Supply Chain, Commercial Execution, IT, Validation, and Quality Assurance teams to ensure end-to-end quality integration.

QM Analyst

Director

• Defining and executing global strategies for externally manufactured biotherapeutic drug products across launch and commercial supply.
• Providing leadership oversight for performance, risk management, and business continuity across the external network.
• Driving alignment between product strategy, network strategy, and enterprise priorities.
• Establishing and leading strategic, long-term partnerships with global CMOs.
• Ensuring effective governance, performance management, and issue escalation across external partners.
• Representing Johnson & Johnson as a senior leader in external manufacturing relationships.
• Ensuring consistent delivery against safety, quality, service, and cost objectives.
• Partnering with Technical Operations and Quality to enable successful tech transfers, lifecycle changes, and capacity expansions.
• Championing continuous improvement, digital enablement, and adoption of industry best practices across the external network.
• Ensuring full compliance with global cGMP requirements and Johnson & Johnson quality standards.
• Maintaining inspection readiness and proactive risk mitigation across all external manufacturing partners.
• Supporting regulatory interactions related to external manufacturing activities.
• Leading, coaching, and developing a high-performing external manufacturing leadership team.
• Serving as an active leader within the broader Manufacturing & Supply organization.
• Influencing senior stakeholders through clear, strategic communication and data-driven insights.

Senior Director, External Manufacturing

Account Executive

• following compliance guidelines, drives sales performance to ensure sales forecasts are met or exceeded within assigned territory by calling on predominantly Primary Care HCP offices and select PC targets within both in-person and virtually.
• Develop superior product and disease state knowledge and effectively educate and engage healthcare professionals in dialogue about clinical evidence, approved indications, and product efficacy/safety profiles to support on-label prescribing for appropriate patients.
• Effectively uses assigned budgets to achieve territory objectives.
• Customizes discussions and client interactions based on customer’s needs in a compliant and ethical manner.
• Function independently with sales proficiency to drive sales performance and ensure sales forecasts and assigned budgets meet or exceed therapeutic and territory expectations.
• Maintains current understanding of local market, practice structures, evolving customers, and key influencers.
• Routinely shares such information with relevant internal Intra-Cellular stakeholders.
• Provides input into resource allocation decisions across customers/region.
• Identifies and selects programs/resources available and appropriate for each customer, practice, and/or system.
• Provides special education to healthcare providers through appropriate programs that fall within ITCI’s ethical guidelines.
• Works with District Manager and key stakeholders to develop a local business plan that ensures achievement of all business objectives.

Neuroscience Sales Representative

• Educate HCPs on product coverage, prior authorizations and appeals, reimbursement processes, claims submissions, procedures, and coding requirements of payer organizations (local payers, government payers, etc.) for core and launch products.
• Collaborate with field support team members such as sales representatives and key account managers and serve as reimbursement experts for the local team.
• Act with a sense of urgency to address critical access and affordability issues for patients.
• Partner with managed care colleagues to understand current policies and potential future changes.
• Conduct field-based reimbursement and access support, education and creative problem-solving aligned to FRM Rules of Engagement.
• Build strong, trust-based relationships with customers in all assigned Immunology accounts.
• Manage territory logistics, routing, and account business planning.
• Maintain and grow knowledge of national, regional, local, and account market dynamics including coverage and coding requirements.
• Grow the knowledge of hub and specialty distribution channels to improve practice and patient support needs.
• Collaborate with internal J&J departments such as marketing, sales, medical science, SCG, IBG, HCC, and PECS.
• Serve as subject matter expert regarding education and insights on access and affordability solutions across multiple payer types and plans (i.e., Medicare, Medicaid Managed Care, Commercial).
• Execute business in accordance with the highest ethical, legal, and compliance standards, including timely and successful completion of all required training.

Field Reimbursement Manager – Immunology, Rheumatology

Sales

• Provide clinical and customer support in hospitals and procedures
• Assist DePuy Synthes sales organization in retaining and supporting further penetration with existing customers
• Assist in the attainment of established sales goals including market share objectives in prescribed territory
• Apply knowledge of sales process, product portfolio and customer knowledge to improve sales outcomes
• Guide and assist surgeons in the operating room through their clinical and product knowledge
• Use product knowledge to present, demonstrate, and ensure proper utilization of DePuy Synthes products
• Support customers by attending surgeries, assuring that the proper equipment is available and performing
• Share key customer, procedural and marketplace insights with other sales, clinical, marketing and strategic account teams to improve on solutions/service levels
• Prepare sales reports and documents as required
• Ensure all promotional materials are maintained in a presentable manner
• Focus on customer satisfaction and retention

Sales Associate – Orthopaedics

Business Operations

• The Director, Transcend will play a critical leadership role within the IM Transcend initiative, a multi-year global business transformation program focused on modernizing end-to-end Supply Chain digital capabilities.
• This role will support the execution of complex global programs by driving operational excellence, program governance, and cross-functional alignment across key business areas.
• As a key representative of Supply Chain Quality organization , the Director will ensure that quality perspectives, requirements, and compliance standards are fully integrated into the Transcend program’s strategy and execution.
• This includes partnering with stakeholders across Supply Chain, Commercial, Finance, Technology, and Quality to embed quality systems and risk-based decision-making into all phases of the transformation.
• The Director will be responsible for implementing and scaling the program operating model, supporting deployment execution, and leading central workstreams that enable transformation across processes, technology, and data.
• This role requires strong collaboration with program leads and stakeholders to ensure consistent delivery, risk management, and resource optimization, while also advocating for the unique needs and priorities of Supply Chain Quality function, including Advanced Therapy Quality, Biotherapeutics Quality, Synthetics Quality, and External Quality.

Director, Business Process Quality

• Sell and manage the Monovisc, Orthovisc, and co-promote Zilretta product lines in the clinical setting within an assigned territory.
• Develop and implement a business plan to improve growth within DePuy Synthes’ Early Intervention product platform.
• Work with Surgeons, Office Staff, Administration, Pain Management Specialists and Rheumatologists throughout various aspects of the product sales cycle.
• Identify and qualify prospective accounts.
• Develop and implement account-specific plans and selling strategies to grow sales and convert new business using various tools.
• Drive product sales within an assigned territory in clinical setting or set of named accounts.
• Present, demonstrate, and ensure proper utilization of products.
• Actively promote special marketing promotions and support strategic selling objectives.
• Gain access to the right customers and build effective relations with key surgeons, office staff, administration, Pain Management Specialists and Rheumatologists throughout various aspects of the product sales cycle.
• Strive to improve patient care and service customers as a problem solver.