Director, Software Validation

Yprime

Company Type
Experience
Responsibilities
Workhours

·        Supervises a team of software testers, performing all necessary duties including budgeting, hiring, project resourcing, training, and other supervisory responsibilities as needed

·        Identify strengths and weaknesses of team members and mentor those individuals to foster professional growth and ensure the success of the team as a whole

·        Serve as a subject matter expert and provide quality oversight on global operational projects, execution of validation activities, and ongoing validation maintenance activities

·        Oversee and execute the validation of new systems; evaluating and performing periodic reviews of existing validated computer systems to ensure / verify continued compliance with appropriate regulations and maintaining required change control procedures

·        Working closely with YPrime Quality Assurance group, ensure YPrime systems are in compliance with applicable regulations including FDA Title 21 Code of Federal Regulations (CFR) Part 11

·        Participate in customer and regulatory audits as software QA subject matter expert

·        Partner with development teams to develop a quality culture. Drive adoption of unit tests, automation, and other quality initiatives to ensure platform and ecosystem robustness

·        Actively participate in project operations and drive strategic initiatives to reduce

time to market, increase quality and expand test automation

·        Assists in aligning project teams (including project managers, business analysts, experience designers, technologists and business stakeholders) around all aspects of software testing and software quality control processes including scheduling, estimation and issue management

·        Create, implement, and maintain KPIs and tracking metrics to monitor individual and team performance.

·        Develops and maintains Standard Operating Procedures (SOPs) and templates specifically related to software validation and testing.

·        As it relates to system quality and system validation, serve as an escalation contact to YPrime customers, internal and external.

·        Serve as a member of the internal YPrime Quality Console, providing routine feedback for continual improvement.

Skills

  • Excels in a team environment with effective communication and a passion to collaborate
  • Deep understanding of clinical trials and software solutions that support them
  • Experience translating business needs into software systems
  • Experience managing large cross-functional teams
  • Ability to multitask and juggle large projects
  • Ability to demonstrate software products in a business development setting

Education and Experience

  • Bachelor's degree in related field or equivalent or five (5) years or relative experience
  • 5+ years of management experience required
  • Experience with testing automation and electronic testing management required
  • Experience with testing software in a controlled, regulated industry
  • Experience in the clinical trial industry experience preferred

Additional Information

  • Up to 25% travel may be required
  • Must be authorized to work in the United States

YPrime is the emerging world leader in precision-engineered software technology designed to support clinical trials. YPrime is easily distinguished from other clinical trial SaaS providers in that it leverages best practices that solve clients’ needs from collaborative design, custom development and project delivery assurance. Unlike the majority of companies that claim to compete, YPrime is the trusted advisor to clients; bringing innovation to each project.

YPrime is unique in that it is the only software company proficient in creating conjointly developed interactive response technology (IRT) and electronic clinical outcome assessments (eCOA) solutions for clinical trials. With over a decade of trust in addressing the most complex needs, clients repeatedly turn to a partner they can count on. For major pharmaceutical / biotech entities seeking an alternative to either paper trials or traditional eCOA / IRT providers, YPrime welcomes the opportunity to introduce a problem-free approach to supporting your research.

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Confirmed 3 hours ago. Posted 30+ days ago.

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