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Senior Associate, Quality Assurance

Replimune
August 20, 2026
Full-time
Remote friendly (Framingham, MA)
Worldwide
Operations
Role: Support GMP compliance within Replimune's Quality Assurance department, focusing on maintaining Quality Management Systems, batch release, and audit preparedness. Responsibilities include performing GMP batch reviews, supporting change control, deviation, CAPA processes, reviewing SOPs and validation documents, and liaising with internal teams and vendors to ensure regulatory and quality standards are met. Qualifications: 3-5 years of biotech/pharma quality experience, with a formal degree or equivalent work background, attention to detail, strong communication skills, and proficiency in Microsoft Office. High-value specifics: GMP environment, biotech focus, supporting regulatory readiness, vendor qualification, and quality documentation review. Work setup: Not specified, but involves cross-functional collaboration.