Sr. Director, Validation - 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: 

The Senior Director of Validation will lead the validation team and oversee all validation activities related to equipment, systems, processes, and computerized systems and software within the company. This is a Global role, responsible for validation activities at the Framingham, MA (US) Manufacturing facility and Milton Park, Abingdon (UK) quality control and development facility. This role is critical to ensuring compliance with regulatory standards and maintaining the highest quality in our products.

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

Leadership and Management:

• Lead and mentor the validation team, fostering a culture of excellence and continuous improvement.
• Develop and implement validation strategies and policies in alignment with regulatory requirements and company goals.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, Quality Control and R&D, to ensure validation activities are integrated into the overall project plans.

Validation Activities:

• Oversee the planning, execution, and documentation of validation activities for equipment, systems, processes, and computerized systems for all GMP and GxP operations.
• Ensure all validation protocols and reports are compliant with FDA, EMA, and other relevant regulatory guidelines.
• Conduct risk assessments and develop mitigation strategies for validation projects.

Regulatory Compliance:

• Stay current with industry trends and regulatory changes to ensure the company’s validation practices remain compliant.
• Represent the company during regulatory inspections and audits, providing expertise on validation matters.
• Develop and maintain validation master plans, standard operating procedures (SOPs), and other documentation.

Continuous Improvement:

• Identify opportunities for process improvements and implement best practices in validation.
• Lead initiatives to enhance the efficiency and effectiveness of validation processes.
• Provide training and development opportunities for the validation team to ensure skill enhancement and knowledge growth.

Other responsibilities

• Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), quality standards, and safety procedures.
• Support equipment and process related non-conformance investigations and change control activities.
• Ensure training for department is kept in GMP compliant state.
• Role is US-based at manufacturing facility in Framingham, MA and will require occasional travel to Milton Park, UK facility.

Education:   

• Bachelor’s or Master’s (preferred) degree in Engineering, Life Sciences, or a related field.

  Required Experience:  

• Minimum of 12+ years of experience in validation within the biotechnology or pharmaceutical industry.
• Excellent knowledge of regulatory requirements, industry standards, and guidance (e.g. 21CFR 210, 211, Part 11, EU Annex 1, EU Annex 15, USP, GAMP, ISO14644, etc.).
• Proven leadership and team management skills.
• Excellent communication and interpersonal skills.
• Detail-oriented with a commitment to quality and compliance.
• Ability to work collaboratively in a fast-paced, dynamic environment.

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.