Senior eQMS & GxP Quality Systems Lead — Hybrid Framingham

Scorpion Therapeutics; Framingham (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Replimune is seeking a Senior Quality Systems Specialist to oversee GxP activities related to electronic Quality Management Systems (eQMS). The role emphasizes compliance, system optimization, and inspection readiness in a hybrid onsite setting in Framingham, MA.

Responsibilities include leading process improvement projects, acting as SME for Veeva QMS and MasterControl, and supporting audits. A bachelor's degree with extensive biopharma experience is required, with advanced expertise considered

Qualifications

• Bachelor's degree with 7+ years in regulated biopharma environments and familiarity with FDA/EU/ICH GxP standards.
• Experience with GMP manufacturing operations and quality systems administration.
• Ability to author and review quality documentation and generate metrics.

Responsibilities

• Lead process improvement projects and serve as SME for Veeva QMS and MasterControl.
• Author and review quality documentation, generate quality metrics, and support audits.
• Manage system administration and validation activities across QA functions.

Skills

Quality systems oversight

GxP compliance

Audit support

Documentation management

Cross-functional collaboration

Education

Bachelor's degree in regulated biopharma field

Tools

Veeva QMS

MasterControl

Job description

Replimune is seeking a Senior Quality Systems Specialist to oversee GxP activities related to electronic Quality Management Systems (eQMS). The role emphasizes compliance, system optimization, and inspection readiness in a hybrid onsite setting in Framingham, MA.

Responsibilities include leading process improvement projects, acting as SME for Veeva QMS and MasterControl, and supporting audits. A bachelor's degree with extensive biopharma experience is required, with advanced expertise considered