Senior Auditor Cell Therapy Quality

Role: Senior QA Auditor specializing in Cell Therapy manufacturing, responsible for conducting highly complex audits of AstraZeneca's manufacturing sites, contractors, and suppliers to ensure cGMP compliance. Responsibilities include planning and executing domestic and international audits across areas like sterile production, APIs, excipients, and packaging; interpreting and applying cGMP and regulatory standards; providing justified findings and recommending corrective actions; liaising with senior management and industry regulators; and maintaining awareness of evolving quality trends. Qualifications: Minimum 10 years in QA with extensive audit experience, a scientific bachelor's degree, and proven expertise in Cell Therapy regulations and cGMP standards. Preferred: experience overseeing audits and in other GXP areas like GCP and GLP. High-Value: Cell Therapy products, advanced GMP environments, international regulatory standards, risk-based compliance assessments; extensive travel (up to 60%). Work setup: Remote or hybrid with locations in Gaithersburg MD, Santa Monica CA, or The Netherlands.