Senior Manager, Software Quality Engineering; V&V

Position: 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…