Associate Director Development Quality
Company: AstraZeneca
Location: Durham
Posted on: February 17, 2026
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Job Description:
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. 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.
Keywords: AstraZeneca, Greenville , Associate Director Development Quality, Science, Research & Development , Durham, North Carolina
