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 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

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

Nice To Haves

• 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

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