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Текст:
Hirify AI/Оригинал
TL;DR
Senior Manager, Software Quality Engineering (V&V) (eCOA Service Delivery Quality Engineering): Establishing software quality standards and leading validation delivery for clinical-trial eCOA projects with an accent on test automation, AI, regulatory expectations, and testing coverage. Focus on managing SQE teams and offshore vendors, improving validation processes, monitoring quality metrics, and resolving delivery risks across the study configuration lifecycle.
Location: Remote in the United Kingdom
Company
hirify.global, part of Thermo Fisher Scientific, develops technology and services that support clinical research and better evidence generation.
What you will do
Lead strategic software quality engineering and validation initiatives across eCOA projects, covering initial releases, reports, translations, change control, and study configuration lifecycles.
Establish quality, documentation, development, testing, maintenance, and technology standards aligned with SOPs and regulatory expectations.
Manage SQE operations, direct reports, project SQE managers, offshore testing vendors, resource planning, hiring, training, performance, and development.
Improve validation capabilities and department efficiency through test automation, AI concepts and tools, industry best practices, and software quality metrics.
Administer JIRA, GIT, and Jama; support audits and CAPA implementation; and manage strategic quality assurance and validation partnerships.
Requirements
BS, BA, or equivalent degree in Information Technology or a related field.
At least 12 years of global clinical operations experience focused on clinical trial phases and associated lifecycles, or at least 12 years of software delivery operations/client operations experience.
At least 10 years of software validation experience, preferably in a regulated environment.
Experience leading software quality engineering, validation delivery, teams, resources, and external testing partners.
Experience with quality standards, testing processes, SOPs, project risk management, quality metrics, and regulatory expectations.
Nice to have
Proven experience in test automation and AI.
Culture & Benefits
Full-time remote work from the United Kingdom with modern technology for remote collaboration.
Competitive compensation and incentives.
Private health, pension, and life insurance.
Engaging employee programs.
Work supporting clinical science, innovative technology, and faster delivery of life-changing therapies.
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