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. We imagine a world where cancer is a curable disease. 

 At Replimune, we live by our values: 

United: We Collaborate for a Common Goal. 

Audacious: We Are Bold and Innovative. 

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, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients, caregivers and themselves.  

 Join us, as we reshape the future. 

Job Summary: 

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 Milton Park location and typically has a 5-day on-site expectation. 

• Provide support of day-to-day operations of the Quality System department for multiple sites and support internal and external customers.
• Lead and Participate in continuous improvement initiatives.
• Review records and documents, for completeness and compliance with global regulations.
• Generate standard operating procedures and/or guidelines to define and improve quality system functions.
• Support and manage document lifecycle the Electronic Document Management System (EDMS).
• Track and trend compliance paperwork (deviations, change controls, etc. both internal and external).
• Oversee training documentation and compliance metrics through use of learning management system (LMS).
• Assist with employee “on-boarding” training on general quality specific procedural requirements.
• Ensure organizational charts are updated on a regular basis.
• Participate in the internal audit program.
• Create and modify user groups, training items, curricula, group trainings and assignments.
• Conduct periodic review and audits of Quality Systems.
• Preparation of Quality metrics.
• Manage the storage and archival of all controlled documents.
• Adhere to company documentation policies and maintaining documentation systems as required.

Education:   

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

Required Experience: 

• Validation of computerized systems with applicable regulations preferred.
• Excellent verbal and written communication skills in group or one-on-one settings.
• Computer skills, e.g., Microsoft Office applications, EDMS.
• Ability to work in a very dynamic environment with a clear sense of urgency.
• Excellent organizational skills and attention to detail and accuracy.
• Performs other related duties and ad hoc projects as required by position.

About Replimune  
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. 

We are an Equal Opportunity Employer. 

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