Principal Associate II, Quality Systems

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, we live by our values:

United:
We Collaborate for a Common Goal.

Audacious:
We Are Bold.

Dedicated:
We Give Our Full Commitment.

Candid:
We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees,
we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

This position provides cross-functional support of GxP activities as they relate to Quality Systems. This position leads the administration, optimization, and continuous improvement of electronic Quality Management Systems (eQMS) to ensure quality processes remain effective, compliant, and inspection ready. The role serves as a subject matter expert for Veeva Quality applications and supports Master Control administration and system governance activities.

This position reports to the Director, Quality Systems and requires extensive experience in GxP compliance, electronic quality systems administration, regulatory requirements, and cross-functional collaboration. The individual works independently to ensure quality system processes, electronic workflows, and system administration activities are maintained in compliance with applicable global regulations and company requirements.

• This position is based in our Framingham location and typically has a 4-day on-site expectation.

• Demonstrate advanced technical knowledge and independent execution of Quality Systems assignments and projects.
• 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.
• Demonstrate advanced knowledge of FDA, EU, ICH, and applicable GxP regulatory requirements.
• Author, review and approve Quality documentation including SOPs, Work Instructions, and Quality Reports.
• Generate, analyze, and report Quality metrics and KPIs to support compliance and management review activities.
• Act as a Quality Systems subject matter expert and provide guidance to stakeholders across the organization.
• Support day-to-day Quality Systems operations for multiple sites and internal customers.
• Lead continuous improvement initiatives focused on Quality Systems and electronic Quality platforms.
• Manage relationships and activities associated with Quality Systems vendors.
• Apply regulatory requirements and industry best practices to ensure compliance of Quality System processes.
• Serve as system administrator and subject matter expert for Veeva Quality applications, including user access management, workflow support, troubleshooting, reporting, dashboard development, system configuration support, and compliance oversight.
• Support administration and governance activities within Master Control, including document control workflows, user access, reporting, and system maintenance activities.
• Lead and support implementation, validation, enhancement, and lifecycle management activities for Quality Systems applications and modules.
• Create and modify user groups, roles, permissions, and system assignments as required.
• Oversee document lifecycle activities including creation, revision, approval, periodic review, archival, and retirement.
• Support document archival processes and controlled record management.
• Partici…