Senior Computer System Validation Specialist

🕒 il y a 19 jours

🗽 New York – Distant

🗽 New York – Remote

💵 $105 000 - $130 000 / an

⏰ Temps Plein

🟠 Senior

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Rochester Regional Health

Site WebLinkedInTous les Emplois

10 000+ employés

🏥 Santé

⚕️ Assurance santé

📚 Éducation

Healthcare • Healthcare Insurance • Education

Rochester Regional Health est une organisation intégrée de services de santé desservant les habitants de l'ouest de l'État de New York. Elle gère plusieurs hôpitaux et établissements de santé, offrant une large gamme de services de santé, y compris les soins d'urgence, les soins primaires, les cliniques spécialisées et les soins d'urgences. L'organisation est engagée dans l'éducation médicale et la recherche, proposant des programmes de formation, des résidences et des essais cliniques. Rochester Regional Health met l'accent sur des soins complets, en traitant les patients avec respect et en répondant à leurs divers besoins médicaux à toutes les étapes de la vie.

Description

• Lead risk-based validation and assurance activities for GxP-regulated computerized systems throughout their lifecycle • Provide technical leadership in validation strategy, execution, quality review, audit and inspection readiness • Serve as a subject matter expert in CSV/CSA, SDLC, data integrity, electronic records/signatures, and regulatory requirements • Plan, execute, review, and approve validation and assurance deliverables for new systems, upgrades, integrations, infrastructure changes, software changes, and retirements • Lead or review system risk assessments, validation strategy assessments, supplier/vendor assessments, impact assessments, and validation planning decisions • Author, review, or approve validation lifecycle deliverables, including URS, specifications, testing protocols, regression testing, UAT evidence, traceability matrices, validation summary reports, periodic reviews, migration, archival, decommissioning, and retirement documentation • Provide IT Quality and Compliance oversight for computerized systems, SDLC activities, validation deliverables, change controls, and lifecycle processes • Support audits, inspections, audit responses, CAPAs, deviations, and remediation plans • Support procurement, implementation, configuration, validation, operational use, change control, periodic review, incident/deviation support, migration, archival, and retirement • Provide senior-level review and guidance for change controls, impact assessments, validation strategy decisions, test planning, evidence review, and release readiness • Coach and mentor CSV/CSA Specialists and cross-functional project teams • Improve validation procedures, templates, guidance documents, training materials, metrics, and operating rhythms • Facilitate cross-functional meetings and communications related to validation strategy, compliance expectations, audit readiness, and lifecycle deliverables

🎯 Exigences

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field OR equivalent combination of education and relevant experience • 5+ years of CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems experience • Strong knowledge of computerized system validation, CSA, GAMP 5, SDLC, GxP, 21 CFR Part 11, EU Annex 11, data integrity, and e-record/e-signature expectations • Strong working knowledge of validation lifecycle deliverables and risk-based validation practices • Ability to interpret regulatory expectations and apply them to system risk, intended use, and business impact • Strong technical writing, documentation review, inspection-readiness, analytical, prioritization, facilitation, and communication skills • Experience leading validation strategy and deliverable execution for laboratory, quality, clinical, enterprise, infrastructure, data, or integration systems • Experience supporting audits, inspections, CAPAs, deviations, remediation activities, SDLC reviews, change controls, testing evidence, data integrity controls, and lifecycle records • Experience mentoring or providing technical guidance to less senior validation or quality resources • Ability to lead complex validation activities across multiple systems, projects, stakeholders, and priorities • Ability to work remotely; East Coast preferred