Senior Manager, Software Quality Engineering (V&V)

Role overview

Lead software quality engineering and validation for electronic clinical outcome assessment projects. You will set standards, manage day-to-day testing operations, and improve validation methods so project deliverables are accurate, timely, and consistently tested. The role also guides quality engineering managers and teams, including offshore testing partners.

Responsibilities

- Establish quality, process, and technology standards for project releases, reports, translations, change control, study configuration, documentation, development, testing, and maintenance. - Manage testing operations, team capacity, project staffing, and offshore quality assurance and validation resources. - Improve validation practices using industry guidance, test automation, and emerging tools, including AI approaches. - Set and report department performance measures for quality, timeliness, and productivity; use metrics to identify and deliver efficiency improvements. - Supervise, hire, train, and develop quality engineering managers and staff, and work with HR on performance and growth. - Advise project leaders on test strategy, schedules, effort estimates, and regulatory expectations; monitor progress, communicate risks, and coordinate mitigation plans. - Maintain quality procedures and department tools, address audit findings, and ensure corrective and preventive actions are implemented.

Requirements

- Bachelor’s degree or equivalent in information technology or a related field. - At least 12 years of experience in global clinical operations focused on clinical trial phases and lifecycles, or in software delivery or client operations. - At least 10 years of software validation experience, preferably in a regulated environment. - Experience leading teams and coordinating validation work across projects and service partners.

Nice to have

- Demonstrated experience with test automation and AI tools or methods. - Familiarity with quality engineering tools such as Jira, Git, and Jama.

Benefits and work setup

- Competitive compensation and incentives, private health, pension, and life insurance, employee programs, and modern tools for remote collaboration.