Associate Director Development Quality at AstraZeneca

Join AstraZeneca as a Lead Quality Advisor, Site Quality (Development Quality).At AstraZeneca, quality is how we deliver on our mission to transform patients’ lives. We’re seeking a Lead Quality Advisor to provide GMP leadership across our development value chain—from internal Drug Substance and Drug Product to Pack & Label and clinical trial supply.In this high‑influence role, you will:Build and translate robust, risk‑based cGMP standards into practice across DevelopmentProvide QA oversight of manufacturing documentation, deviations, risk assessments, and SOPsRelease internal Drug Substance, Drug Product, and IMP for clinical trials (DevQ release)Lead/host regulatory inspections and contribute to audits, Data Integrity, Self‑Inspection, and QRM programsApprove equipment/facilities documentation (maintenance, calibration, validation, change control)Drive continuous improvement, lean ways of working, and inspection readiness in a global networkApply leadership skills/experience to help develop this role for the future.What you’ll bring:Science degree with extensive experience in pharmaceutical GMP: ideally 5–10+ years of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisationDeep QA expertise in Quality Systems, cGMP, and the end‑to‑end drug development processStrong scientific understanding of product modalities you’ve supportedIndependent judgment, risk‑based decision‑making, and influential communication across interfacesCredibility in the QA community and a drive for excellenceEssential requirements:BS degree with extensive experience (5-10 years) of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organizationExtensive experience from working in a Quality Assurance function is essential;A broad and comprehensive understanding of Quality Systems and GMPA comprehensive understanding of the pharmaceutical/drug development processA detailed scientific understanding of the Product types being supportedGood knowledge and reputation in the QA arena and specifically in GMP mattersExcellent team working and networking skills and encourages team efficiencyDemonstrates independent judgement and uses risk management in complex situationsCapable of making decisions, acting fearlessly and presenting with conviction and inspirationDemands excellence (sets high bar) and deliversA good communicator with experience of interacting effectively across interfacesBuilds excellent relationships both internally and with external suppliers or service providersDemonstrates drive and energy in the role to make a difference.Demonstrates a high degree of personal credibilityImpact. Scale. Purpose. Help us compose standards that safeguard patients and enable life‑changing medicines worldwide.Date Posted18-Mar-2026Closing Date31-Mar-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.SummaryLocation: US - Durham - NCType: Full time