Quality Systems Lead – eQMS & GxP Expert

Replimune; Framingham (MA); On-site; USD 134,000 - 174,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Replimune is seeking a Quality Systems SME to support GxP compliance and eQMS administration from our Framingham, MA location. You will oversee Veeva Quality applications and MasterControl governance, ensuring inspection readiness and continuous improvement across sites.

The role demands extensive experience with regulatory requirements, SOP governance, and cross-functional collaboration to drive quality initiatives and maintain compliant processes in a fast-paced biopharma environment.

Qualifications

• Bachelor's degree in a regulated manufacturing field or equivalent experience.
• Minimum 7 years of experience in pharmaceutical/biotech or related regulated industries.
• Extensive experience administering Veeva Quality applications and electronic Quality Management Systems.
• Experience with MasterControl is preferred.

Responsibilities

• Demonstrate advanced technical knowledge and independent execution of Quality Systems assignments.
• Lead and manage Quality Systems process improvement and remediation initiatives.
• Serve as Quality Systems representative on multiple GxP projects.
• Support Regulatory Inspection activities and inspection readiness initiatives.
• Author, review and approve Quality documentation including SOPs and Quality Reports.
• Generate and report Quality metrics to support compliance and management reviews.
• Act as a Quality Systems SME and guide stakeholders across the organization.

Skills

Quality Systems

GxP compliance

Cross-functional collaboration

Documentation governance

Regulatory awareness

Education

Bachelor's degree in regulated manufacturing

7+ years pharma/biotech experience

Tools

Veeva Quality applications

MasterControl

Job description

Replimune is seeking a Quality Systems SME to support GxP compliance and eQMS administration from our Framingham, MA location. You will oversee Veeva Quality applications and MasterControl governance, ensuring inspection readiness and continuous improvement across sites.

The role demands extensive experience with regulatory requirements, SOP governance, and cross-functional collaboration to drive quality initiatives and maintain compliant processes in a fast-paced biopharma environment.