Associate Director Development Quality

AstraZeneca • Durham, NC

10d

About The Position

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

Requirements

• 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
• 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

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees