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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Director, Computerized Systems Validation (CSV) - **Company:** Johnson & Johnson - **Location:** Horsham, PA, United States - **Experience:** Expert - **Salary:** $150,000.0 - $258,750.0 - **Contract:** Permanent contract - **Skills:** Artificial Intelligence, Software Applications, Audit Trail, Cloud Computing, Software Quality, Information Systems, Data Integrity, Systems Development Life Cycle, Role-Based Access Control, System Testing, Systems Integration, Strategies of Testing, Computerised Systems, Information Technology, GXP - **Published:** May 23, 2026 - **Apply:** https://www.juju.com/job/00000000g1s0q5 ## About the Role + A Bachelor's degree in Computer Science, Information Systems, Business Administration or another related field is required; Advanced degree is preferred. Experience and Skills: Required: + 10-12 years of experience leading GxP computerized systems validation (CSV) within pharmaceutical, medical device, biotech industry, or other regulated industries. + Deep understanding of GxP regulations and compliance requirements, including data integrity, SDLC governance, validation lifecycle managements, electronic records/signatures, audit trails, and inspection readiness. + Thorough knowledge of global cGMP regulations and computerized systems requirements including: + 21 CFR Part 11, + Emerging Annex 22 expectations + Data integrity guidance + Risk-based validation and Computer Software Assurance (CSA) principles. + Proven experience providing Quality and Compliance oversight for large scale ERP platform implementations, upgrades, integrations, and lifecycle management activities within regulated environments. + Strong knowledge of ERP ecosystems supporting Finance, Supply Chain, Manufacturing, Procurement, Quality, Warehouse Management, and Planning functions. + Experience leading risk-based validation strategies, and compliance activities for enterprise ERP platforms and supporting digital ecosystems. + Strong experience with Computer System Validation (CSV), Computer Software Assurance (CSA), change control, deviation management, CAPAs, periodic reviews, and validation governance processes. + Experience overseeing validation deliverables and compliance activities associated with ERP implementations including intended use, risk assessments, requirement traceability testing strategies, defect management, and validation summary reporting. + Direct experience supporting regulatory inspection, internal audits, supplier audits, and health authority inspection involving GxP computerized systems and ERP platforms. + Demonstrated people leadership experience managing and developing global, matrixed, and geographically distributed teams. + Experience leading organizational development activities including hiring, performance management, coaching, mentoring, succession planning, talent development, resource management, and organizational capability building. + Strong executive presence with ability to influence and collaborate with senior business, Quality, and technology leaders across global organizations. + Proven experience managing multi-million-dollar platform implementation and operational budgets, including financial planning, forecasting, and cost optimization. + Experience leveraging automation, advanced analytics, AI-enabled technologies, and digital capability to improve validation efficiency, and operational performance. + Understanding of cybersecurity, privacy, and digital risk management principles and their impact on GxP quality systems, validation activities, and regulator technology platforms. + Experience applying security role design, role-based access controls (RBAC), and segregation of duties principles across enterprise technology platforms, and integrated digital ecosystems. Preferred: + Certified Software Quality Engineer (CSQE), Certified Quality Engineer (SQE), Certified Quality Auditor (SQA), Project Management Professional (PMP) or similar ## Description Johnson & Johnson is currently recruiting for a **Director, Computerized Systems Validation** **(CSV)** position to be located in either **Raritan, NJ, Horsham, PA** or **Beerse, Belgium** ., + This role must ensure that all J&J quality standards and global regulatory requirements are being met + This role ensures that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible + The role provides TQ&C expertise/guidance to the project teams + This individual must drive the implementation and maintenance of systems to be delivered on time, within budget and with high quality + This individual must provide end-to-end Technology Quality leadership support to projects and base business support teams across applications and cloud infrastructure + This individual will lead the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope + Partners with Regional Leads in support of the TQ&C Operating Model + This role will lead global teams with unique skills in cross-functional environments. + This role will provide an environment which encourages the company's credo and the value of a diverse workforce + This role serves as a trusted partner across the Technology Quality & Compliance organization, requiring collaboration skills at the senior leadership level, both internally and externally ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) - [Resilient by Design: Building Robust Architectures in High-Stakes Financial Systems](https://www.wearedevelopers.com/videos/2106-resilient-by-design-building-robust-architectures-in-high-stakes-financial-systems) - [Exploring 5 Key Applications of AI Abundance with Blockchain Assurance](https://www.wearedevelopers.com/videos/971-exploring-5-key-applications-of-ai-abundance-with-blockchain-assurance) - [GenAI Security: Navigating the Unseen Iceberg](https://www.wearedevelopers.com/videos/1744-genai-security-navigating-the-unseen-iceberg) - [Startup Presentation: StorX - Future of Cloud Storage](https://www.wearedevelopers.com/videos/1176-startup-presentation-storx-future-of-cloud-storage) ## Related Articles - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [System change: restart as developer?](https://www.wearedevelopers.com/magazine/39-system-change-restart-as-developer) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Quick guide: How to write a Software Developer CV](https://www.wearedevelopers.com/magazine/37-quick-guide-how-to-write-a-software-developer-cv)