Enterprise Quality R&D Clinical Computer System Validation

Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager Join to apply for the Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager role at Johnson & Johnson. Location: Horsham, PA; Raritan, NJ; Beerse, Belgium or Allschwil, Switzerland. About the Role Enterprise Quality (EQ) manages the Quality and Compliance strategy for IT systems across applications, infrastructure and digital health solutions. The EQ team is the Subject Matter Expert for validation/qualification of both applications and infrastructure in accordance with J&J’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, ensuring compliance across the enterprise with applicable global regulations and assisting with closing compliance gaps related to audits and inspections. Key Responsibilities Ensure that all J&J quality standards and global regulatory requirements are met. Incorporate early quality involvement in design and development activities, including building controls within application/solution and using automation whenever feasible. Own the quality approach for systems and ensure teams are accountable for an end‑to‑end support model for systems in scope. Provide technical and procedural expertise to project teams, aligning with internal and external stakeholders. Plan, task and resource allocations; execute, coordinate and maintain validation activities for GxP systems/applications. Support internal audits and Health Authority regulatory inspections. Approve SDLC validation documentation deliverables and oversee release of system implementation and/or changes for production use. Lead globally diverse teams in an inclusive environment, encouraging a diverse workforce and the company’s credo. Qualifications Education Bachelor’s or equivalent degree in Computer Science, Information Systems, Business Administration, Science, Engineering or another related field. Experience and Skills Required 8‑10 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities. Experience running large‑scale end‑to‑end validation programs such as LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling and Change Control. Experience authoring or approving validation protocols, non‑conformities, change requests, SOPs, validation plans and reports. Proficiency with tools such as JIRA, HPALM, Xray, Qtest, Jenkins, Selenium. Direct experience working in a software development environment using Agile, SAFe, CI/CD. Direct experience in Artificial Intelligence (AI) and Machine Learning (ML). Direct experience in CSV Quality and/or CSV for R&D systems. Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820. Knowledge of SDLC Quality Management process and Computerized System Validation/Computerized System Assurance principles. Preferred Understanding of data integrity throughout the lifecycle of technology solutions. Ability to define testing strategy according to risk assessment. Experience with testing management tools like HPALM, JIRA with Xray, Selenium. Implementation of elements of an effective quality management system. Application of digitization tools, techniques and automation to software development and validation processes. Understanding of best practices for architecting effective data solutions and frameworks. Knowledge of global regulations such as EU Annex 11, SOX, HCC, Security & Privacy, ISO. Familiarity with PMO, SDLC, GAMP 5 and ITIL frameworks. Desirable: Agile, SAFe, CI/CD, RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain, Kubernetes, XaaS, SaMD. Other Requirements Proficiency in the English language, both written and oral, is required. Up to 10% travel, both international and domestic, may be required. May have 0‑1 direct reports. EEO Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource. Salary and Benefits Base pay range: $102,000.00 – $177,100.00. Benefits include: Vacation – 120 hours per calendar year Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents) 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 birth/adoption/foster care of a child Bereavement leave – 240 hours for an immediate family member; 40 hours for an extended family member per year Caregiver leave – 80 hours in a 52‑week rolling period Volunteer leave – 32 hours per calendar year Military spouse time‑off – 80 hours per calendar year Retirement participation: company’s consolidated retirement plan (pension) and savings plan (401(k)). #J-18808-Ljbffr