Manager, Quality Assurance Operations

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: 

The Manager, Quality Assurance Operations (QA Ops) reports to the Associate Director QA Ops and is responsible for on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing practices (cGMP), good documentation practices (GDP) and other applicable regulations. The Manager QA Ops will work with cross functional teams to maintain and present the internal quality systems associated with GxP activities to ensure the successful and timely release of drug substance, drug product and clinical trial material by providing quality oversight of the overall release, packaging and labeling processes. The Manager QA Ops will provide leadership, direction and delegation of work to the QA Ops staff.

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

Responsibilities

Key responsibilities:

• Ensures the implementation and maintenance of Quality Management System (change control, deviation and investigation management, corrective and preventive action systems, Quality Control release testing, batch release) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies.
• Evaluate and report on the performance of the QMS via key performance indicators and metric reporting, driving continuous improvement.
• Maintain inspection readiness for the Framingham quality function and participate in regulatory agency inspections as needed
• Oversees and provides direction for the Quality Assurance staff to ensure batch release, label processes, raw material release, compliance, training and documentation functions are performed effectively.
• Establish and communicate departmental team member’s individual performance expectations and objectives.
• Perform batch release for GMP lots, including final Quality Review of associated quality records. Prioritize batch release in support of business needs including maintaining batch release status and communicate release needs throughout the organization.
• Work cross functionally with internal customers in Product Development, Operations, Quality Control, and Clinical groups to ensure inspection readiness. Provide QA input and approvals to assist in and drive projects as needed.

Other responsibilities

• Promote GxP and Quality mindset at all levels within the organization.
• Ensures Quality Assurance staff are appropriately trained on an ongoing basis and have complete training records.
• Assist in setting objectives for Quality Assurance staff
• Support Replimune Clinical Quality Assurance activities
• Performs other related duties and ad hoc projects as required by position

Qualifications

Education:   

• Bachelor’s degree required; MSc or PhD preferred

Required Experience: 

• 5-7 years of experience working in the biopharmaceutical industry.
• Proven leadership in managing and motivating administrative and technical staff with strong awareness of the interface among Quality Assurance, Quality Control, manufacturing operations, and pre-clinical development.
• Knowledge of FDA, MHRA and ICH guidelines regarding GMPs
• Excellent verbal and written communication skills
• Strong organizational skills

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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