Senior Associate, Quality Assurance

About the Company

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

About the Role

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

Responsibilities

• Provide day-to-day support for the Quality Assurance department to ensure the implementation and maintenance of the Quality Management System (QMS) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies.
• Aid in preparation for inspection readiness and actively participate during inspections and audits.
• Perform batch release for GMP lots, including final Quality Review of associated quality records to ensure closure, and preparation of batch release documentation for completeness and accuracy in accordance with procedure.
• Prioritize batch release in support of business needs, maintain batch release status, and communicate release needs throughout the organization.
• Support oversight of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems, including support of thorough root cause analysis investigations related to quality issues.
• Assist in tracking and populating QMS metrics related to change controls, CAPAs, and deviations.
• Conduct or participate in the Change Control Review Board.
• Support vendor qualification process, issuance of vendor questionnaires, and authoring of vendor quality technical agreements.
• Support supplier corrective action notification and request, and vendor notification systems, when applicable.
• Review and approve Standard Operating Procedures (SOPs), Validation Protocols/Reports, Production Records, GMP records, Testing Records, and Engineering Drawings, ensuring internal and external standards are met.
• Interface and provide support to internal customers in Product Development, Quality Control Labs, etc., and external vendors to support ongoing compliance with Replimune requirements and quality standards.
• Draft, review, provide oversight to content, and approve controlled documents, which may include SOPs, validation documents, and material specifications.
• Work cross-functionally with Quality Assurance, Quality Control, Regulatory, and Clinical groups to ensure commercial readiness for licensure.

Requirements

• A minimum of a formal degree; Associates plus applicable work experience may be considered.
• 3-5 years of quality experience in the biotech or pharmaceutical industry.
• High level of attention to detail and excellent time management.
• A very organized and methodical approach to tasks.
• Strong written and verbal communication skills to interact with other functions.
• Competency in using Microsoft Office.
• A level of flexibility to meet varying workloads.

Pay

Replimune is committed to fair and equitable compensation practices. For this role, the anticipated base pay range is $106,000 - $137,000. The exact base pay offered will depend on various factors, including qualifications, skills, experience, and organizational needs. Base pay is only one part of the total compensation package, which also includes:

• Annual performance incentive bonus.
• New hire equity and ongoing performance-based equity.
• Medical, dental, and vision insurance.
• 401k match.
• Flexible time off and paid holidays, including year-end shutdown.

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 versatility in development alone or combined with a variety of other treatment options. For more information, visit www.replimune.com.