QA Software Testing Manager
Core
Manage a team of software testing engineers to implement high-quality software solutions for regulated Medpace applications.
Role type
Senior QA Software Testing Manager
Builds
Regulated software applications for clinical research
Domain
Healthcare / Clinical Research / GxP
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
SDLC management, software validation, team leadership, change control, GxP compliance, SOx compliance, risk management, traceability matrix creation, audit participation
Preferred skills
Agile environment experience, regulated industry background, supervisory experience, Good Clinical Practice knowledge, 21 CFR Part 11 knowledge
Technologies
Validation tools, documentation systems
Responsibilities
Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables; Coordinate and assign systems and projects to validation staff; Maintain oversight of validation staff in managing change control; Ensure compliance of computer systems with GxP and SOx regulatory requirements; Ensure compliance of system validation SOPs with regulatory requirements; Lead validation team in implementing tools and procedures; Participate in Sponsor audits
