Senior Associate, Plant Quality Assurance

Role: Senior Associate, Plant Quality Assurance supporting drug manufacturing operations at Replimune, with a focus on cGMP compliance for Drug Substance, Drug Product, and Quality Control. Responsibilities: provide on-floor QA oversight during second shift, perform quality walkthroughs and inspections, review batch records and quality documentation, support deviation and CAPA processes, participate in root cause investigations, and assist in audit readiness and regulatory inspections. Requirements: BA/BS in a scientific field; 3-5+ years in pharmaceutical/biotech regulated industry, with minimum 3 years in QA, QC, or manufacturing roles; strong knowledge of cGMP, GDP, and quality systems; excellent communication and collaboration skills in fast-paced environments. Preferred: GMP documentation review experience, background supporting manufacturing of biologics or cell/gene therapies, and familiarity with validation and risk assessments. HighValue: role supports biologics manufacturing in a regulated GMP setting, with involvement in quality oversight for client drug development. WorkSetup: based in Framingham, MA with a 5-day onsite expectation, no travel specified.