This position will manage a team of software testing engineers and software validation projects to implement effective and high quality software solutions.
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.
Qualifications
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 in English;
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!
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