Associate Director Development Quality
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Job Location:
Durham, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
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. Were seeking a Lead Quality Advisor to provide GMP leadership across our development value chainfrom internal Drug Substance and Drug Product to Pack & Label and clinical trial supply.
In this highinfluence role you will:
- Build and translate robust riskbased 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 SelfInspection 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 youll bring:
- Science degree with extensive experience in pharmaceutical GMP: ideally 510 years of working within a pharmaceutical GMP environment preferably within a pharmaceutical development organisation
- Deep QA expertise in Quality Systems cGMP and the endtoend drug development process
- Strong scientific understanding of product modalities youve supported
- Independent judgment riskbased decisionmaking 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 lifechanging medicines worldwide.
Date Posted
26-Jan-2026Closing Date
08-Feb-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.
Required Experience:
Director
Key Skills
- Fundraising
- Management Experience
- Biotechnology
- Clinical Development
- Clinical Trials
- Research & Development
- Training & Development
- Grant Writing
- Economic Development
- Leadership Experience
- Public Speaking
- Product Development
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
