Senior Manager, Software Quality Engineering (V&V)

Join Clario, part of Thermo Fisher Scientific, as a Senior Manager, Software Quality Engineering, leading the development and execution of strategic initiatives within eCOA Service Delivery Quality Engineering.

This includes establishing and implementing process and technology standards for all eCOA projects to ensure quality and timeliness for all deliverables.

This role is accountable for the delivery of accurate and dependable products that meet customer needs with the overarching goals of increased customer satisfaction, reduced cycle times, increased efficiency and completeness of testing coverage at all stages of testing.

What We Offer

• Competitive compensation and incentives.
• Private health, pension, and life insurance.
• Engaging employee programs.
• Modern technology for remote collaboration.

What You'll Be Doing

• Establishes and implements process and technology standards for all eCOA projects to ensure quality and timeliness for all deliverables (Initial Release, Reports, Translations, and Change Control).
• Works with SQE V&V Department Leader on management of offshore testing vendors, including resource management and capacity planning
• Redefines processes and procedures related to system validation by leveraging industry best practices and stronger alignment to technology advancements such as test automation and AI.
• Drive improvements in validation capabilities by applying test automation and AI concepts and tools.
• Establishes software quality standards for study configuration life cycle, documentation, development methods, testing and maintenance.
• Manages the day-to-day operations within the QA testing department, including direct reports and offshore team. This includes approving timesheets, reviewing training records to ensure all staff members are in compliance, as well as resolving issues and conflicts regarding project progress.
• Works with Managers to improve department efficiency without sacrificing quality by introducing best practices, test automation etc. through collection and analysis of software quality metrics.
• Partners with HR on hiring, development, and performance management of team members.
• Resource reallocation: Works with managers and team leads to rearrange SQE resource as needed within the squad teams
• Builds departmental strategies aligned to support Corporate Goals and positions tactical plans to ensure delivery excellence.
• Develops, maintains & reports key performance Indicators within department and with technology and service partners to ensure quality, timeliness and productivity goals are met.
• Directly supervises the performance of the Project SQE Managers, providing leadership and solving technical challenges as necessary. Hires, trains and manages SQE Managers/ personnel.

Other responsibilities:

• Writes, maintains and contributes to all Service Delivery QA standard operating procedures as needed.
• Attends all Project review meeting (DSE, Ops review etc.,)
• Ensures the quality and timely delivery of all software validation efforts. Provides insight and guidance to the project team management on testing approach, best practices, scheduling, effort estimations, regulatory expectations, etc. Ensures that validation efforts are completed in accordance to Clario SOPs.
• Monitors project testing progress daily, reviews issues and develops mitigation plans for projects that are at risk of not completing on time, or do not complete on time. Follows up with appropriate staff to communicate risks and plan to move forward.
• Manages and administers the systems and tools used in the department (JIRA, GIT, Jama)
• Responds to audit observations and ensures implementation of any CAPAs.
• Reviews all projects status with team and resolves any risks with a goal of meeting all target dates without fail.
• Implements new tools and process as necessary
• Works with managers to provide guidance on individual development and growth plans
• Manages strategic services and technology business partnerships including Offshore Quality Assurance/Validation resources

What We Look For

• 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 a strong plus.

At Clario, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.

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Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. We offer comprehensive evidence generation solutions that combine medical imaging, eCOA, precision motion, cardiac solutions and respiratory endpoints.

For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported over 30,000 clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2015.