Global QA & QMS Analytics Specialist (AIQ)

BioPharma Consulting JAD Group

Cambridge (MA)

On-site

USD 110,000 - 140,000

Full time

6 days ago
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Job summary

BioPharma Consulting JAD Group is seeking a Specialist/Sr. Specialist for Global Audits, Inspections, and QMS (AIQ) in Cambridge, MA. The role supports QMS initiatives, reporting, and data analysis for quality systems across deviations, CAPAs, and change controls.

The position emphasizes training, KPI dashboards, and AI-enabled analytics while maintaining GxP compliance and data integrity. Candidates should have GMP/GLP/GCP knowledge and strong Excel skills.

Qualifications

  • Bachelor’s degree in Life Sciences, Engineering, or related discipline is required.
  • 3-5 years of experience in GxP Quality Systems, QA operations, or QMS program support.
  • Strong understanding of GMP, GLP, GCP regulations and ICH guidelines.

Responsibilities

  • Support deviation investigator training pilot program with adult-learning principles.
  • Develop training materials (case studies, templates, guidance tools) for investigations.
  • Partner with QA and deviation owners to create a sustainable support model.
  • Analyze training metrics (investigations quality, cycle times, rework) for improvements.
  • Support QMS data governance, dashboards, and KPI frameworks.
  • Assist with data aggregation, trending, and routine reporting for reviews.

Skills

Analytical thinking
Excel proficiency
Project management
Communication
Influence without authority
Technical writing

Education

Bachelor’s degree in Life Sciences, Engineering, or related discipline

Tools

Excel
Power BI

Job description

BioPharma Consulting JAD Group is seeking a Specialist/Sr. Specialist for Global Audits, Inspections, and QMS (AIQ) in Cambridge, MA. The role supports QMS initiatives, reporting, and data analysis for quality systems across deviations, CAPAs, and change controls.

The position emphasizes training, KPI dashboards, and AI-enabled analytics while maintaining GxP compliance and data integrity. Candidates should have GMP/GLP/GCP knowledge and strong Excel skills.

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