Associate Director/Director, Supplier Quality Management

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. 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.  

 Join us, as we reshape the future. 

Job Summary: 

This role provides cross-functional support for GXP activities as they relate to Supplier Quality. This position will support the qualification, oversight, and performance monitoring of suppliers in accordance with the applicable governing regulations, as well as internal Replimune policies and procedures.  In addition, this position is responsible to help drive strategic improvements to the Supplier Management Program.

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

Responsibilities

Key responsibilities:

• Work to ensure suppliers of materials and services supporting GMP operations are qualified and approved in accordance with Replimune’s governing policies and procedures.
• Continue to build and implement the Supplier Quality Management program in support of ongoing clinical operations, as well as future commercial operations.
• Oversee the development of supplier Quality Agreements (QTAs), ensuring that all standards and specifications are clearly communicated.
• Oversee the maintenance and control of the Approved Supplier List (ASL) supporting GMP operations.
• Collaborate cross-functionally/ cross-site to drive improvements to the Supplier Quality Management program, as well as to ensure internal processes support best practices and requirements.
• Work to always ensure a state of inspection readiness for the operations with respect to Supplier Quality Management.
• Lead the internal Supplier Review Board to monitor and track Quality performance of suppliers supporting GMP operations.
• Work to help establish KPIs and metrics and track supplier performance driving accountability and improvements.
• Participate in material risk assessments as needed to support ongoing work.
• Participate in the evaluation of Supplier Change Notifications (SCNs) as needed.
• Report on the performance of the suppliers during regular Quality Councils as required.
• This role is accountable for building strong partnerships with suppliers, driving quality improvements, and following all operational and quality standards.

Other responsibilities:  

• May be asked to conduct supplier audits as needed. 
• Some travel may be required (10-20%)

Qualifications

Education:   

• Bachelor’s degree preferably in the life sciences with practical experience in a regulated manufacturing environment

Required Experience: 

• A minimum of 7 years of relevant Quality experience required, with at least 3-5 years of experience in Supplier Quality Management support functions
• 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.
• Knowledge of Supplier Quality Management program.
• Strong knowledge of US-FDA, ISO, ICH, GxP principles, and other global regulations for drugs and medicinal products.
• Proficient in Microsoft suite (Word, Excel, PowerPoint, Access and Outlook).
• Excellent written and oral communication skills.
• Ethical, self-motivated and self-directed.
• Experience conducting supplier quality audits preferred.

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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