Manager, Process and Validation

Technology & Analytics Iselin, New Jersey


Position at Medidata Solutions

Medidata: Conquering Diseases Together

 

Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. 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 1,400 customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, 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.

Your Mission: 

This role is responsible for operational management of software validation activities, Quality System process updates, and contributing to continuous improvement initiatives focused on the improvement of product quality and compliance with the Medidata QMS and applicable regulatory expectations.

  • Management of direct reports to include the planning/oversight of assignments, conducting performance reviews, and coaching

  • Contributing to the development of team members to increase their depth of knowledge and soft skills

  • Assist with providing support for routine P&V operations and workload management   

  • Lead Quality System process engineering efforts within Technology and author procedural documents 

  • Lead process improvement initiatives

  • Conduct and/or lead periodic quality reviews of Medidata software

  • Manage and plan validation projects for assigned software products

  • Provide guidance to Technology teams on Technology QS processes and/or other relevant QS processes and practices

  • Represent Medidata’s SDLC and CSV processes in customer audits

  • Prepare and/or assist other Technology staff with remedial actions (corrective and/or preventive actions) in response to customer feedback on SDLC and CSV processes and/or validation packages.  

  • Design and deliver/facilitate training to Technology staff

  • Serve as a subject matter expert on SDLC and CSV

  • Participate in the product management of the Validation Portal and related validation tools

  • Perform assigned P&V SDLC/CSV initiatives/projects under the direction of senior department management

Your Competencies: 

  • Ability to work with cross-functional teams

  • Ability to effectively communicate process expectations to the teams

  • Ability to evaluate issues and resolve problems or propose resolutions

  • Ability to identify risks and take appropriate measures to minimize negative outcomes

  • Ability to understand and articulate technical issues 

  • Project management and people management skills

  • Excellent attention to detail

  • Proficiency in the use of office productivity tools (e.g. Smartsheets, WebEx, MS Word, etc.)

  • Ability to effectively manage several projects simultaneously  

  • Ability to travel up to 20% of time

Your Education & Experience:

  • University degree, preferably in Computer Science, Information Technology, or related discipline

  • Solid demonstrable knowledge of office productivity tools (e.g. Smartsheets, WebEx, MS Word, etc.)

  • 5+ years of management responsibility 

  • 7+ years Software development and/or software validation/testing experience, in a regulated environment preferred

  • 7+ years of experience in an Agile software development environment 

  • Solid knowledge of Life Sciences (pharmaceutical, biotech, medical devices) regulatory requirements

  • Relevant experience in the application of SDLC and validation best practices in the Life Sciences industry

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.

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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