Senior Quality Systems Lead - eQMS & GxP Expert

Replimune-2; 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 seeks a Quality Systems specialist to administer and optimize eQMS platforms, ensuring regulatory compliance and inspection readiness. The role supports governance, workflows, and cross-functional collaboration across sites.

The ideal candidate has deep GxP experience, strong documentation skills, and proficiency with Veeva Quality and MasterControl. Based in Framingham, this role emphasizes on-site work four days/week.

Qualifications

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

Responsibilities

• Demonstrate advanced knowledge of Quality Systems and execute projects independently.
• Lead Quality Systems process improvements and remediation initiatives.
• Serve as Quality Systems SME on multiple GxP projects and audits.
• Support regulatory inspection readiness activities and regulatory requirements.

Skills

Quality Systems

GxP compliance

Regulatory requirements

Cross-functional collaboration

Documentation management

Veeva Quality

Education

Bachelor's degree

Advanced degree preferred

Tools

MasterControl

Veeva Quality applications

Job description

Replimune seeks a Quality Systems specialist to administer and optimize eQMS platforms, ensuring regulatory compliance and inspection readiness. The role supports governance, workflows, and cross-functional collaboration across sites.

The ideal candidate has deep GxP experience, strong documentation skills, and proficiency with Veeva Quality and MasterControl. Based in Framingham, this role emphasizes on-site work four days/week.