Medpace ยท 21 hours ago
QA Software Testing Manager
Medpace is a full-service clinical contract research organization (CRO) that provides Phase I-IV clinical development services. They are seeking a Software Testing Manager to lead a team of software testing engineers and manage validation projects to ensure high-quality software solutions in compliance with regulatory requirements.
BiotechnologyPharmaceutical
Responsibilities
Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test Plans, User Requirements & Functional Specifications, Functional & User Acceptance Testing, Traceability Matrices, and Validation Summary Reports
Coordinate and assign systems and projects to validation staff according to priorities, timelines and availability
Maintain oversight of validation staff in managing change control of Medpace software applications
Ensure compliance of Medpace computer systems with GxP and SOx regulatory requirements
Ensure compliance of system validation Standard Operating Procedures (SOPs) with regulatory requirements
Ensure consistency of systems validation SOPs with best practices of industry
Lead validation team in implementing tools and procedures to facilitate validation and documentation activities; and
Participate in Sponsor audits
Qualification
Required
Bachelor's Degree
7+ years of experience in SDLC, testing, and validation, preferably in an Agile environment and/or regulated industry
Advanced knowledge of software development life cycle
Knowledge and understanding of the application of Risk Management concepts
Excellent analytical, written, and oral communication skills
Preferred
Previous supervisory experience
Experience in the regulated healthcare industry, with working knowledge of Good Clinical Practice and 21 CFR Part 11
Benefits
Flexible work environment
Competitive PTO packages, starting at 20+ days
Competitive compensation and benefits package
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Community involvement with local nonprofit organizations
Discounts on local sports games, fitness gyms and attractions
Modern, ecofriendly campus with an on-site fitness center
Structured career paths with opportunities for professional growth
Discounted tuition for UC online programs
Company
Medpace
Medpace, Inc., a clinical research organization, provides clinical development services for pharmaceutical and biotechnology
H1B Sponsorship
Medpace has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (29)
2024 (21)
2023 (19)
2022 (22)
2021 (22)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
unknown2016-08-10IPO
2014-02-24Acquired
Recent News
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