Global QMS & Quality Analytics Specialist

BioPharma Consulting JAD Group; Cambridge (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

BioPharma Consulting JAD Group is seeking a QMS and Reporting Support Contractor in Cambridge, MA to enable multiple QMS initiatives and support reporting and data analysis deliverables. The role partners with GxP stakeholders for data input and deviation ownership.

Responsibilities include developing training materials, supporting KPI dashboards, and driving data governance and continuous improvement within QMS processes.

Qualifications

• Bachelor's degree 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 training program and model execution.
• Develop training materials (case studies, templates, guidance tools).
• Partner with QA and deviation owners to establish a sustainable support model.
• Analyze training program effectiveness metrics to inform improvements and scalability.
• Support execution and delivery of Quality scorecards, dashboards, and KPI frameworks.
• Perform data aggregation, trending, and root-cause analysis across deviations, CAPAs, and change controls.
• Support routine reporting requests for Quality Management Review and Quality Systems forums.
• Provide project management support across QMS initiatives (timelines, deliverables, follow-ups).
• Assist with process mapping, gap assessments, and continuous improvement initiatives across QMS processes.
• Support data governance and data clean-up initiatives within the QMS.
• Leverage Alnylam approved AI tools and technologies to advance analytics and enable Quality record completeness and accuracy.

Skills

GxP Quality Systems

QA operations

Quality metrics

Data analysis

Excel

Power BI

Data governance

GxP compliance

AI tools

Documentation

Project coordination

Education

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

Tools

Veeva

Job description

BioPharma Consulting JAD Group is seeking a QMS and Reporting Support Contractor in Cambridge, MA to enable multiple QMS initiatives and support reporting and data analysis deliverables. The role partners with GxP stakeholders for data input and deviation ownership.

Responsibilities include developing training materials, supporting KPI dashboards, and driving data governance and continuous improvement within QMS processes.