Senior Manager, Software Quality Engineering – V&V

🔥 48 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

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Clario

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1973

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private Equity Round on 2019-10

Healthcare • Consulting • Logistics

Clario is a company specializing in accelerating clinical trials from initiation to implementation through advanced technologies and services. Since 2018, Clario has revolutionized endpoint analyses in clinical trials by integrating over 30 artificial intelligence-enabled solutions across more than 600 active trials, enhancing data quality and patient privacy while expediting data collection processes. Clario provides a comprehensive clinical trial management platform, offering solutions such as eCOA, cardiac safety, medical imaging, precision motion, and respiratory services in various therapeutic areas including oncology, cardiology, and neurology. Known for its global reach, Clario supports clinical trials in over 100 countries with a strong focus on decentralized and hybrid trial models. The company's commitment to patient safety and innovation is reflected in their over 26,000 trials and involvement in numerous new drug approvals.

📋 Description

• Lead strategic initiatives within eCOA Service Delivery Quality Engineering • Establish and implement process and technology standards for all eCOA projects and deliverables • Manage offshore testing vendors, resources, and capacity planning • Redefine system validation processes using industry best practices, test automation, and AI • Drive improvements in validation capabilities through test automation and AI tools • Establish software quality standards across study configuration, documentation, development, testing, and maintenance • Manage day-to-day QA testing department operations, direct reports, and offshore teams • Approve timesheets, review training records, and resolve project progress issues and conflicts • Improve department efficiency through best practices, test automation, and software quality metrics • Partner with HR on hiring, development, and performance management • Reallocate SQE resources within squad teams • Build departmental strategies and tactical plans aligned with corporate goals • Develop, maintain, and report departmental KPIs • Supervise Project SQE Managers and resolve technical challenges • Hire, train, and manage SQE personnel • Maintain Service Delivery QA standard operating procedures • Attend project review meetings • Ensure timely, compliant delivery of software validation efforts • Advise project teams on testing approaches, best practices, scheduling, effort estimates, and regulatory expectations • Monitor testing progress, review issues, and develop mitigation plans for at-risk projects • Administer JIRA, GIT, and Jama • Respond to audit observations and implement CAPAs • Review project status and resolve risks to meet target dates • Implement new tools and processes • Guide individual development and growth plans • Manage strategic services and technology partnerships, including offshore QA/validation resources

🎯 Requirements

• BS, BA or equivalent in an Information Technology or related field required • Minimum 12 years Global Clinical Operations experience with a focus on the clinical trial phases and associated lifecycles OR minimum 12 years' experience in Software Delivery Operation (Client Operations) • Minimum 10 years of software validation experience, preferably in a regulated environment • Proven experience in Test Automation and AI is a strong plus • Experience managing offshore testing vendors, resources, and capacity planning • Experience with software quality standards, system validation, testing, and maintenance • Experience with JIRA, GIT, and Jama • Experience with KPIs, software quality metrics, and regulatory expectations • Experience hiring, training, supervising, and managing SQE personnel

🏖️ Benefits

• Competitive compensation and incentives • Private health insurance • Pension • Life insurance • Engaging employee programs • Modern technology for remote collaboration