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Software Quality Assurance Manager
2 months ago
Job Overview:
As our organization continues to expand, we are in search of a dedicated Software Quality Assurance Manager to become a vital part of our Information Technology division.
This role will oversee a team of quality assurance engineers and software validation initiatives to ensure the delivery of effective and high-quality software solutions.
If you are looking for a rewarding career where you can leverage your existing skills while also advancing your professional development, this opportunity is tailored for you.Key Responsibilities:
Direct the validation team in the creation, coordination, and upkeep of comprehensive SDLC validation documentation for regulated software applications, including Validation & Test Plans, User Requirements & Functional Specifications, Functional & User Acceptance Testing, Traceability Matrices, and Validation Summary Reports;
Assign and manage systems and projects to validation personnel based on priorities, timelines, and resource availability;
Oversee validation staff in managing change control processes for software applications;
Ensure that Medpace computer systems adhere to GxP and SOx regulatory standards;
Guarantee that system validation Standard Operating Procedures (SOPs) align with regulatory requirements;
Maintain consistency of systems validation SOPs with industry best practices;
Guide the validation team in adopting tools and procedures that enhance validation and documentation efforts; and
Engage in Sponsor audits;
Required Qualifications:
Bachelor's Degree;
7+ years of experience in SDLC, testing, and validation, ideally within an Agile framework and/or regulated sector;
In-depth understanding of the software development life cycle;
Familiarity with Risk Management principles;
Strong analytical, written, and verbal communication abilities;
Prior supervisory experience is advantageous; and
Experience in the regulated healthcare sector, with knowledge of Good Clinical Practice and 21 CFR Part 11, is a plus.
About Medpace:
Medpace is a comprehensive clinical contract research organization (CRO) that provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device sectors.
Our mission is to expedite the global development of safe and effective medical therapies through a scientific and disciplined approach.
We utilize local regulatory and therapeutic expertise across all major areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective.
We employ over 5,000 individuals across more than 40 countries.Why Choose Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The efforts we have made over the past 30+ years have positively influenced the lives of countless patients and families facing various diseases across all key therapeutic areas.
Benefits of Working in Cincinnati
Hybrid work-from-home options (dependent upon position and level)
Competitive PTO packages, starting at 20+ days
Attractive compensation and benefits package
Flexible work schedule
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Community involvement with local nonprofit organizations
Discounts on local sports events, fitness centers, 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
Recognized as a Top Workplace in 2024 by The Cincinnati Enquirer
Honored by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024
Consistently acknowledged with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.