Principal Associate II, Quality Systems

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

Role: Senior Quality Systems Specialist supporting GxP activities related to electronic Quality Management Systems (eQMS) at Replimune, focusing on compliance, system optimization, and inspection readiness.

Responsibilities

• lead process improvement projects, serve as subject matter expert for Veeva Quality applications and MasterControl, author and review quality documentation, generate quality metrics, support audits, and manage system administration and validation activities. Collaborate cross-functionally across manufacturing, quality, and regulatory teams to ensure GxP compliance.

Requirements

• Bachelor's degree with at least 7 years of experience in regulated biopharma environments, extensive Veeva QMS administration expertise, knowledge of FDA, EU, ICH GxP standards, and familiarity with GMP manufacturing operations.

Preferred

• advanced degree, experience with MasterControl, and supporting commercial manufacturing.

High-Value

• focus on quality system oversight within a biologics/gene therapy setting, supporting regulatory inspections and validation activities, with a hybrid onsite requirement in Framingham, MA.