QA Software Testing Manager
About the Role
We are seeking a full-time Software Testing Manager to lead a team of software testing engineers and validation projects, ensuring the implementation of effective and high-quality software solutions for our rapidly growing corporate activities.
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 the industry.
- Lead the validation team in implementing tools and procedures to facilitate validation and documentation activities.
- Participate in Sponsor audits.
Requirements
- Bachelor’s Degree.
- 7+ years of experience in SDLC, testing, and validation, preferably in an Agile environment and/or regulated industry.
- Advanced knowledge of the software development life cycle.
- Knowledge and understanding of the application of Risk Management concepts.
- Excellent analytical, written, and oral communication skills.
- Previous supervisory experience is preferred.
- Experience in the regulated healthcare industry, with working knowledge of Good Clinical Practice and 21 CFR Part 11, is a plus.
About Medpace
Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs more than 6,000 people across 40+ countries.
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, eco-friendly campus with an on-site fitness center.
- Structured career paths with opportunities for professional growth.
- Discounted tuition for UC online programs.
Awards & Recognition
- Named a Top Workplace in 2024 by The Cincinnati Enquirer.
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024.
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.