Associate Director Development Quality

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 Development
• Provide QA oversight of manufacturing documentation, deviations, risk assessments, and SOPs
• Release 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 programs
• Approve equipment/facilities documentation (maintenance, calibration, validation, change control)
• Drive continuous improvement, lean ways of working, and inspection readiness in a global network
• Apply 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 organisation
• Deep QA expertise in Quality Systems, cGMP, and the end‑to‑end drug development process
• Strong scientific understanding of product modalities you’ve supported
• Independent judgment, risk‑based decision‑making, and influential communication across interfaces
• Credibility in the QA community and a drive for excellence

Essential requirements:

• BS degree with extensive experience (5-10 years) of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organization
• Extensive experience from working in a Quality Assurance function is essential;
• A broad and comprehensive understanding of Quality Systems and GMP
• A comprehensive understanding of the pharmaceutical/drug development process
• A detailed scientific understanding of the Product types being supported
• Good knowledge and reputation in the QA arena and specifically in GMP matters
• Excellent team working and networking skills and encourages team efficiency
• Demonstrates independent judgement and uses risk management in complex situations
• Capable of making decisions, acting fearlessly and presenting with conviction and inspiration
• Demands excellence (sets high bar) and delivers
• A good communicator with experience of interacting effectively across interfaces
• Builds excellent relationships both internally and with external suppliers or service providers
• Demonstrates drive and energy in the role to make a difference.
• Demonstrates a high degree of personal credibility

Impact. Scale. Purpose. Help us compose standards that safeguard patients and enable life‑changing medicines worldwide.