QA Software Testing Manager

• 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

Do you have experience in Risk & issue management?, Do you have a Bachelor's degree?, * 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;
• Previous supervisory experience is preferred; and
• Experience in the regulated healthcare industry, with working knowledge of Good Clinical Practice and 21 CFR Part 11, is a plus!

Pulled from the full job description

• Paid time off
• On-site gym, * 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

Awards

• 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

Medpace is a full-service clinical contract research organization (CRO). We provide 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries. Why Medpace?: People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.