Validation Manager

Job Summary
The Validation Manager, R&D IT is responsible for implementing a computer software assurance strategy for the R&D IT department. This includes reviewing and revising the existing processes and procedures, implementing an ALM tool and ensuring its successful adoption within R&D, and developing validation templates.

A successful candidate will have recent CSA experience, an understanding of the regulatory landscape, and familiarity with validating SaaS applications, laboratory instruments and applications, and AI models.
Responsibilities
Validation Strategy

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  Subject matter expertise with GAMP 5 principles, US Code of Federal Regulations, and EU Annex 11 regulations
  
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  Subject matter expertise in computer software assurance principles
  
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  Ability to review processes and procedures and implement a comprehensive and compliant computer software assurance strategy
  
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  Ability to lead and facilitate meetings, interact with relevant stakeholders, and build strong relationships
  
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  (~10% of role)
  

Technical Writing

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  Ability to write technical documents such as Standard Operating Procedures (SOPs), Work Instructions (WIs), and informal training documentation
  
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  Ability to write Validation Templates in accordance with Standard Operating Procedures and relevant Regulatory guidelines
  
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  Ability to write validation documents to support the implementation of software applications
  
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  (~30% of role)
  

System Implementation

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  Ability to implement a GxP SaaS-based electronic validation application, including project management and all relevant validation documentation
  
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  Ability to drive adoption of the new application in accordance with the policies and procedures
  
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  Validation support for other projects and applications in accordance with policies and procedures
  
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  (~60% of role)
  

Other duties as assigned
Essential Skills

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  Lead Self
  
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  Lead Others
  
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  Strategic Thinking
  
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  Digital Acumen
  
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  Problem Solving
  
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  Communication
  
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  Project Management
  
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  Leadership
  
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  Collaboration
  
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  Motivate & Influence
  
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  Technical & Functional Skills
  

Experience with:

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  Computer System Validation, Computer Software Assurance and GxP relevant applications
  
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  Writing standard operating procedures, validation templates, validation deliverables
  
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  Running projects and strategy initiatives
  

Minimum Qualifications

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  Bachelor’s Degree in Computer Science / Information Systems or related discipline
  
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  5–7 years of experience in a position of equal scope and responsibility
  
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  Experience in the pharmaceutical or medical device industry
  

Preferred Qualifications

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  Recent experience with CSA and ALM implementation
  
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  Experience with CSA of SaaS applications
  
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  Experience with CSA of laboratory instruments, IPCs, and applications
  
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  Experience with CSA or CSV of AI models
  

Travel Requirements

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  At least 3 days in office
  

Physical Requirements
This position requires you to sit, stand and perform general office functions. You may also be required to lift up to twenty-five pounds occasionally. Bending, stooping and reaching are also frequently required.

Target Pay Rate Range: $70-80/hr depending on experience