Senior Associate, Quality Systems

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 Audacious:
We Are Bold. Dedicated:
We Give Our Full Commitment. Candid:
We Are Honest With Each Other. United:
We Collaborate for a Common Goal. People are at the center of everything we do, and when it comes to our employees, we make it personal.

Join us, as we reshape the future.

This position provides cross-functional support of GXP activities as they relate to Quality Systems. This position will participate in the improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

• Archive, organize, and maintain controlled documents and records in compliance with quality and regulatory requirements.
• Coordinate the shipment, tracking, storage, and retrieval of documents sent to off-site archival facilities.
• Prepare, verify, and package-controlled documents for off-site archival storage, ensuring accuracy, completeness, and compliance with document retention procedures.
• Create, issue, and maintain logbooks, laboratory notebooks, and batch records to support operational and quality system activities.
• Manage and prioritize document-related requests through the Jira ticketing system, ensuring timely resolution and customer support.
• Process, route, review, and maintain controlled documents within the Master Control electronic document management system. Includes formatting documents, creating training courses, etc.
• Ensure document accuracy, version control, and compliance with established procedures and Good Documentation Practices (GDP).
• Support document lifecycle activities, including creation, revision, approval, distribution, archival, and retirement of quality system documents.
• Collaborate with cross-functional departments to facilitate document control processes and maintain audit-ready records
• Provide support of day-to-day operations of the Quality System department for multiple sites and support internal and external customers.
• Administered and supported the Master Control document management system, managing user access, document workflows, troubleshooting, and compliance with quality system requirements.
• Assist with employee "on-boarding" training on general quality specific procedural requirements.
• Participate in the internal audit program.
• Create and modify user groups, training items, curricula, group trainings and assignments.
• Assist with preparation of QMS metrics.
• Support continuous improvement projects to enhance quality system performance and operational efficiency.
• Support Quality Records, VEEVA system. Create reports, dashboards, ability to pull metrics and assist in admin type activities.

• Highly motivated individual with excellent time management skills.
• Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
• Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
• Proficient in Microsoft suite (Word, Excel, PowerPoint, Access and Outlook).
• Excellent written and oral communication skills.
• Ethical, self-motivated and self-directed.
• Ability to lift boxes

• Experience with electronic document and quality management systems, including Master Control and Veeva.

• Bachelor's degree with practical experience in a regulated manufacturing environment or equivalent experience
• A minimum of 4 years of relevant experience required.

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $101,500- $131,500 The exact base pay offered for this role will depend on various factors, including but not limited to the selected…