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 Data Integrity and Validation throughout the GxP organization. This position will provide comprehensive mentoring, oversight and monitoring of compliance for all applicable regulations spanning operations and IT.

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

Key responsibilities:

Responsible for Quality oversight of Validation activities with a focus on data integrity, ensuring accurate, consistent, and complete data is available throughout the data life cycle and in support of requirements for data retention. A critically important aspect of this role is monitoring quality processes ensuring processes are not at risk for data loss or manipulation. Overtime, data must be maintained across formats. This is a continual process involving various processes, rules, and standards. Cross functional collaboration is essential to succeeding in this role.

• Represent QA on diverse project teams ensuring development, implementation, maintenance of compliance strategy with an emphasis on risk-based approaches with a quality mindset.
• As an SME for data integrity, provide support to risk assessment teams for change control, and for assessment of impact during quality investigations.
• As it relates to data handling and computer systems, ensure alignment of computer systems access and data handling solutions with supporting validation and process validation(s) across all GMP regulated functions.
• Ensure principles of data integrity are considered in the design and day to day operations of GxP operations.
• Support delivery of shared efficiencies and optimization for shared services relating to data integrity.
• Facilitate the roadmap of activities needed to ensure and maintain data integrity controls and their effectiveness and continuous improvement agenda in a compliant manner.
• Promote/support development & implementation of a data integrity maturity model resulting in measurable and sustainable compliance.
• Serve as a subject matter expert in Data Integrity across operations and quality, supporting cross functional initiatives throughout the Quality System.
• Responsible for developing collaborative partnerships with the partner enterprise team, validation team, risk management, and operations stakeholders. Maintain a trusted partner relationship and advisor to all stakeholders.
• Lead and deliver system(s) practices and procedures with assurance of data integrity.
• Provide project management support and implementation as needed to drive compliant solutions and partnerships.
• Support definition and closure of quality records related to digital solutions and / or data integrity.

Other responsibilities:

• Additional Responsibilities as required.

Education:   

• Bachelor's degree, with a focus in computer systems, mathematics or the life sciences preferred

Required Experience: 

• A minimum of 5-8 years of relevant experience required with practical experience in a regulated manufacturing pharmaceutical environment or equivalent experience.
• Demonstrated critical thinking and project management experience
• Proficiency in SmartSheet and the Microsoft Office tools commonly used in project management

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. 

#LI-onsite