Principal I Associate, Quality Systems/Learning and Development - Replimune, Inc.

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 becausepatient’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 tothe 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 at Replimune Inc., and the Learning and Development program to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness. This position reports to the Director, Quality Systems-Framingham, MA.

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

• Manage activities in LMS (MasterControl)
• Identify and with assistance assess future and current training needs through job analysis, career paths, and consultation with Quality leadership and functional managers.
• Support the generation of overall or individualized training and development plan(s) that addresses needs and audit readiness expectations.
• Deploy a wide variety of training methods (including but not limited to training delivery)
• Conduct Quality orientation and other training sessions such as introduction to QS processes (Document Control and Training)
• Monitor and evaluate training program’s effectiveness periodically and report on them. Generate training program quality system metrics and present to management.
• Provide opportunities/identify training courses for ongoing development.
• Resolve any specific problems and tailor training programs, as necessary.
• Maintain an understanding of training trends, developments, and best practices.
• 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 training records and documents, for completeness and compliance with global regulations.
• Generate standard operating procedures and/or guidelines to define and improve Training/Learning and Development process.
• Assist with document lifecycle the Electronic Document Management System (EDMS).
• Execute Deviations/Investigations/CAPAs as assigned.
• Execute 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.
• Manage the storage and archival of all controlled training 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 5-8 years of relevant experience required.

Required Experience: 

• Proven work experience in Learning and Development
• Track record in designing and executing successful training programs
• Familiarity with traditional and modern training methods (mentoring, coaching, on-the-job or in classroom training, e-learning, workshops, simulations etc)
• Excellent communication and leadership skills
• Ability to plan, multi-task and manage time effectively
• Strong writing and record keeping ability for reports and training manuals
• Good computer and database skills
• Experience with eQMS (MasterControl and/or Veeva) preferred
• BS degree in Health Sciences, education, or relevant field
• 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.
• Location: Framingham

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.