Alexion Pharmaceuticals, Inc. · 18 hours ago
Associate Director Development Quality
Durham, North Carolina, United States of America
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expAlexion Pharmaceuticals, Inc. is seeking a Lead Quality Advisor to provide GMP leadership across their development value chain. This role involves overseeing manufacturing documentation, leading regulatory inspections, and driving continuous improvement within a global network.
BiotechnologyHealth CareMedicalTherapeutics
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
Qualification
Required
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
Preferred
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
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
BioWorld Financial Watch
2026-01-17
bloomberglaw.com
2025-12-20
Company data provided by crunchbase