Senior Manager, Software Quality Engineering – V&V

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Lead strategic initiatives within the eCOA Service Delivery Quality Engineering team.

• Establish and implement standards for processes and technology applicable to all eCOA projects and deliverables.

• Oversee offshore testing vendors, manage resources, and handle capacity planning.

• Redefine system validation processes by leveraging industry best practices, test automation, and AI technology.

• Propel enhancements in validation capabilities through the use of test automation and AI tools.

• Set software quality benchmarks across study configuration, documentation, development, testing, and maintenance.

• Direct daily operations of the QA testing department, including management of direct reports and offshore teams.

• Approve timesheets, assess training records, and address project progress issues and conflicts.

• Enhance departmental efficiency by applying best practices, test automation, and software quality metrics.

• Collaborate with HR on recruitment, employee development, and performance management.

• Reallocate SQE resources across squad teams as needed.

• Formulate departmental strategies and tactical plans that align with corporate objectives.

• Develop, sustain, and report on departmental KPIs.

• Supervise Project SQE Managers and troubleshoot technical challenges.

• Recruit, train, and oversee SQE personnel.

• Maintain the Service Delivery QA standard operating procedures.

• Participate in project review meetings.

• Ensure the timely and compliant delivery of software validation efforts.

• Provide guidance to project teams regarding testing methodologies, best practices, scheduling, effort estimates, and regulatory standards.

• Monitor testing progress, evaluate issues, and formulate mitigation plans for projects at risk.

• Administer tools such as JIRA, GIT, and Jama.

• Address audit observations and implement Corrective and Preventive Actions (CAPAs).

• Review project status and mitigate risks to adhere to target deadlines.

• Introduce new tools and processes as necessary.

• Support individual development and growth plans.

• Manage strategic services and technology partnerships, including offshore QA and validation resources.

⛳️ Requirements

• Bachelor's degree (BS, BA) or equivalent in Information Technology or a related field is required.

• At least 12 years of experience in Global Clinical Operations with a focus on clinical trial phases and their lifecycles, or a minimum of 12 years in Software Delivery Operations (Client Operations).

• A minimum of 10 years of software validation experience, ideally within a regulated environment.

• Strong background in Test Automation and AI is a significant advantage.

• Experience in managing offshore testing vendors, resources, and capacity planning.

• Familiarity with software quality standards, system validation, testing, and maintenance practices.

• Proficient in the use of JIRA, GIT, and Jama.

• Experience with KPIs, software quality metrics, and understanding of regulatory expectations.

• Experience in hiring, training, supervising, and managing SQE personnel.

🏝️ Benefits

• Competitive salary and incentives.

• Private health insurance coverage.

• Pension plan.

• Life insurance benefits.

• Engaging employee programs.

• Access to modern technology for remote collaboration.