Associate Director Development Quality
AstraZeneca, Durham, North Carolina, United States, 27703
Overview
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.
Responsibilities 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.
Date information Date Posted 26-Jan-2026
Closing Date 08-Feb-2026
Our 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.
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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.
Responsibilities 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.
Date information Date Posted 26-Jan-2026
Closing Date 08-Feb-2026
Our 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.
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