Specialist – Quality & Computer System Validation
United States - NJ, Iselin
Medidata: Powering Smarter Treatments and Healthier People
Medidata, a Dassault Systèmes company, is leading the digital transformation of life sciences, creating hope for millions of people. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Known for its ground-breaking technological innovations, Medidata has supported more than 30,000 clinical trials and 9 million study participants. And Medidata’s ongoing commitment to infusing the patient voice into trial designs and solutions is helping to create a better and more inclusive experience for all participants in clinical studies. Medidata is involved in nearly 40% of company-initiated trial starts globally, with studies conducted in more than 140 countries. More than 70% of novel drugs approved by the Food and Drug Administration (FDA) in 2022 were developed with Medidata software. Medidata is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @medidata.
Process and Validation is the Quality arm of the Technology Department within the R&D organization. Our mission is to ensure operational processes and practices in place for Software Development and Validation are aligned with customer quality expectations, applicable regulatory requirements, and Medidata's quality standards. Our team is responsible for the Software Development Lifecycle process for all products at Medidata and performs an independent review of all validation documentation.
What we're looking for:
As the Specialist - Quality & Computer System Validation, you would be responsible for:
- Demonstrate 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.
- Ensure the Quality processes are aligned with Medidata's strategic direction of DevOps and Automation led approach.
- Manage Medidata's Quality Management System specific to Validation responsibilities.
- Ensure alignment of our SDLC to Good Clinical Practices framework.
- Ensure Medidata’s Quality System Documents (QSDs) and Quality System Supporting Documents (QSSDs) as it relates to Computer System Validation are according to the global regulations.
- Ensure the QSDs and QSSDs are maintained to allow quality and compliant products.
- Ensure an automation led Continuous Validation approach aligned with DevOps and Agile Engineering processes.
- Work and manage globally distributed quality & validation teams supporting global engineering teams.
- Represent Medidata in external and internal audits related to regulatory matters together with the Global Compliance and Strategy (GCS) group.
- Mentor and guide the engineering teams to build quality and compliance as part of the engineering process.
- Participate in Proposal/Bid development, client interactions and stakeholder management.
- Strong knowledge of procedures and best practices related to Computer System Validation as it relates to GxP systems.
- Strong knowledge of Software Quality Management and of Software Development Life Cycle for Healthcare and Regulatory industry.
- Experience with Agile Engineering methodology.
- Experience with problem solving and risk assessment/mitigation.
- Strong team member with demonstrated ability to work collaboratively with others.
- Attention to detail and quality focused.
Requirements (Education and Skills):
- A minimum of 10+ years of experience in working, managing and/or 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, EMA 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 plus years of experience with external partners for IT projects
The salary range posted below refers only to positions that will be physically based in New York City / New Jersey. As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location. Pay ranges for candidates in locations other than NYC / NJ, may differ based on the local market data in that region. The base salary pay range for this position is $114,750 to $141,488.
Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata’s non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides best-in-class benefits, including medical, dental, life and disability insurance; 401(k) matching; unlimited paid time off; and 10 paid holidays per year.