Quality Associate II, Quality Assurance

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.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

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, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description:

This position will be required to interact with all departments within the company and to proactively support GMP compliance. The role provides an opportunity to enhance quality skills and experience within a GMP environment.

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

Key responsibilities:

· Provide support for the day-to-day operation of the Quality Assurance department to ensure the implementation and maintenance of Quality Management System (QMS) in accordance with applicable standards established by MHRA, EMA, FDA and other regulatory bodies.

· Assist and perform batch review for GMP lots, in support of Qualified Person release 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.

· Assist with the oversight of Replimune GMP compliance and Quality systems: Change control, Deviation, and Corrective and Preventive actions (CAPA).

· Assist thorough root cause analysis (RCA) investigations related to quality issues.

· Review and approve Standard Operating Procedures (SOPs), Deviations, CAPAs, Validation Protocols/Reports, Testing Records and CoAs, ensuring internal and external standards are met.

· Conduct routine compliance oversight activities e.g. facility/laboratory walkarounds.

· Assist in tracking and populating QMS metrics.

· Interface and provide support to internal customers in Product Development, Quality Control Labs, etc., and, as appropriate, with external vendors to support ongoing compliance with Replimune requirements and quality standards.

· Prepare and issue controlled logbooks for internal customers.

· Archive and retrieval of documentation.

Other responsibilities

· Drafts, reviews, provides oversight to content, and approves controlled documents which may include but is not limited to standard operating procedures, validation documents, material specifications, etc.

· Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to support Replimune Clinical and Commercial operations.

· Other duties as assigned.

Educational requirements:

· A minimum of a bachelor’s degree (BSc or equivalent).

· Masters preferred.

Experience and skill requirement:

· ≥ 2 years’ experience in relevant Quality Systems in a regulated biotechnology or pharmaceutical industry environment.

· High level of attention to details and excellent time management.

· Strong written and verbal communication skills to interact with other functions.

· IT skills – competent in using Microsoft Office.

· An interest in pharmaceutical Quality Assurance.

· A level of flexibility is essential to meet varying workloads.

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.