Senior Associate, 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.

Summary of job description:

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.

Key responsibilities:

• 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 MasterControl 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 MasterControl 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.

JOB REQUIREMENTS:

• 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 <15lbs

Preferred Qualifications:

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

Educational requirements:

• Bachelor's degree with practical experi