Senior Global QMS & Audit Analytics Specialist

Biopharma-Consulting-Jad-Group; Cambridge (MA); On-site; USD 55,000 - 96,000; Full time

Job summary

AIQ is seeking a QMS and Reporting Support Contractor to enable multiple QMS initiatives and support reporting and data analysis deliverables. The role partners with GxP stakeholders to provide data input and deviation record ownership.

The position emphasizes training program execution, quality metrics support, and use of AI-enabled tools while ensuring data integrity and regulatory compliance.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• 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
• Quality Management System processes
• Quality metrics, dashboards, and KPI development
• Data analysis and trending (Excel, Power BI, or equivalent tools)
• Electronic quality management systems (Veeva strongly preferred)

Responsibilities

• Support deviation investigator training pilot program with adult learning principles.
• Develop training materials (cases, templates, guidance tools) to improve investigations.
• Partner with QA and deviation owners to establish a sustainable support model.
• Analyze training metrics to inform program improvements and scalability.
• Support quality scorecards, dashboards, and KPI frameworks.
• Perform data aggregation, trending, and root-cause analysis across deviations, CAPAs, and change controls.
• Support routine and ad hoc reporting for Quality Management Review.
• Provide project management support across QMS initiatives.
• Assist with process mapping, gap assessments, and continuous improvement in QMS.
• Support data governance and data clean-up in the QMS.
• Leverage Alnylam approved AI tools to advance analytics and data integrity.

Skills

Strong process thinking

Excel

Analytical skills

Communication & facilitation

Influence without authority

Technical writing

AI-enabled tools usage

Education

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

Tools

Power BI

Veeva

Job description

AIQ is seeking a QMS and Reporting Support Contractor to enable multiple QMS initiatives and support reporting and data analysis deliverables. The role partners with GxP stakeholders to provide data input and deviation record ownership.

The position emphasizes training program execution, quality metrics support, and use of AI-enabled tools while ensuring data integrity and regulatory compliance.