Validation Manager - Largeton Group : Job Details

Validation Manager

Largeton Group

Job Location : Raleigh,NC, USA

Posted on : 2025-07-13T00:45:31Z

Job Description :
Job Summary (Validation Manager – Raleigh, NC)
  • Location: Hybrid role based in Raleigh, NC (3 days onsite required)
  • Contract Duration: 5 months
  • Work Hours: Monday to Friday, 8:00 AM – 5:00 PM
  • Interview Process: Video/Phone, final round may be onsite
Key Responsibilities
  • Develop and implement a comprehensive computer software assurance (CSA) strategy for the R&D IT department.
  • Review, revise, and improve existing validation processes and procedures.
  • Oversee the implementation and adoption of an ALM tool within R&D.
  • Create and maintain validation templates and technical documentation (SOPs, work instructions, training materials).
  • Lead and facilitate meetings with stakeholders; build and maintain strong professional relationships.
  • Ensure compliance with GAMP 5, US Code of Federal Regulations, and EU Annex 11 regulatory requirements.
  • Provide validation support for SaaS applications, laboratory instruments, and AI models.
  • Manage and support additional validation projects as required.
Required Skills & Experience
  • Bachelor's degree in Computer Science, Information Systems, or related field.
  • 5–7 years of relevant experience, ideally within the pharmaceutical or medical device industry.
  • Strong knowledge of GAMP 5, US and EU regulatory frameworks, and CSA principles.
  • Hands-on experience with Computer System Validation (CSV), Computer Software Assurance (CSA), and GxP applications.
  • Experience with SaaS validation, laboratory instrument validation, and AI model validation.
  • Proven ability to write technical validation documents and manage project deliverables.
  • Demonstrated experience leading projects and strategic initiatives.
Physical Requirements
  • Ability to sit, stand, bend, stoop, and reach as needed for general office functions.
  • Occasionally lift up to 25 pounds.
Preference
  • Medical device industry experience is highly desirable.
  • Candidates must be local to Raleigh, NC for the duration of the contract.
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