Principal - Quality and Computer System Validation

Technology & Analytics Iselin, New Jersey New York, New York


Position at Medidata Solutions

>www.medidata.com.

Your Mission:

Medidata is the leader in developing the technologies that allow our customers to get the medicines to patients faster.  Building on our long history of delivering world-class clinical applications to the life sciences industry, Medidata’s Product Organization is staffed with a passionate team of product management experts, tackling the industry’s most difficult technical challenges in order to push the boundaries of possibility for our clients and most importantly, for patients. Together we can deliver meaningful advanced digital transformation to the industry in order to achieve our vision. 

As the Quality and Computer System Validation (QCSV) Specialist, you would be responsible for

  • Demonstrating Medidata's commitment to develop, deliver, implement, and maintain quality software products and services that meets the expectation of its clients and ensure compliance with applicable regulatory requirements
  • Ensuring the Quality processes are aligned with Medidata's strategic direction of DevOps and Automation led approach
  • Manage and maintain Medidata's Quality Management System specific to Validation responsibilities
  • Ensuring alignment of our SDLC to Good Clinical Practice framework
  • Ensuring Medidata has its Quality System Documents (QSD) as it relates to Computer System Validation is in line with the global regulations
  • Ensuring the QSDs are maintained to enable engineer quality and compliant products
  • Ensuring an automation led Continuous Validation approach aligned with DevOps and Agile Engineering processes
  • Working and managing globally distributed quality & validation teams supporting global engineering teams
  • Representing Medidata in external and internal audits related to regulatory matters in conjunction with the Global Compliance group
  • Mentoring and guiding the engineering teams to build quality and compliance as part of engineering process
  • Participating in Proposal/Bid development, client interactions and stakeholder management

Your Competencies:

  • Strong knowledge of procedures and best practices related to Computer System Validation as it relates to GxP system.
  • Strong knowledge of Software Quality Management and of Software Development Life Cycle for Healthcare and Regulatory industry
  • Strong understanding of Agile Engineering methodology
  • Excellent communication and documentation skills
  • Strong attention to detail and quality focused

Your Education & Experience:

  • A minimum of 10+ years of experience in managing and leading validation groups supporting GxP software products for Computer System Validation
  • Hands on experience with supporting software products for global regulations like MHRA, FDA, CFDA and others
  • A Bachelor's degree or equivalent work experience
  • Hands on experience with supporting Agile Engineering methodologies
  • 5+ years of experience with supporting automation led Quality and Compliance processes
  • Hands on experience with Agile tools
  • A minimum of 5+ years of experience working with external partners for IT projects

Note: The requirements should reflect your minimum requirements for the role in general

Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development, enabling life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of most exciting areas for global innovation. Nine of the top 10 best-selling drugs in 2017 were developed on the Medidata platform.

Medidata’s solutions have powered over 14,000 clinical trials giving us the largest collection of clinical trial data in the world. With this asset, we pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of quality and efficiency to clinical trials enabling treatments to reach waiting patients sooner.

EEO Statement

US:
Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. 



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