Principal Associate I, Digital Quality

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 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 can be based either in our Woburn or Framingham/Hybrid office or be a remote role 

 

• Remote candidates (i.e., living beyond 65 miles of our Woburn HQ or Framingham locations) must be open to 10-25% travel to our Woburn HQ or Framingham locations, every 4-6 weeks or as business needs require.  

 

 

Responsibilities

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.

Qualifications

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