Alexion Pharmaceuticals, Inc. · 20 hours ago
Senior Specialist, External Quality
New Haven, CT
Full-time
Onsite
Senior Level
5+ years expAlexion Pharmaceuticals, Inc. is seeking a Senior Specialist for External Quality who will provide oversight of quality activities associated with drug substance, drug product, and manufacturing processes to contract manufacturing organizations. The role involves ensuring compliance with industry standards and regulatory requirements while supporting quality assurance responsibilities and continuous quality system improvements.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Serving as Quality Assurance support and SME for Drug Substance, Drug Product and maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant
Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug Product and Finished Product
Providing oversight to continuous quality system improvements and support implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact Alexion
Working closely to build relationships with contract manufacturers quality personnel
Working closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events
Reviewing contractor documents i.e., Batch records, deviations and change controls to ensure that they comply with Alexion procedures and meet Alexion standards
Approving Alexion specific standard operating procedures and controlled documents issued by contract manufacturing organizations
Supporting contract manufacturing organization audits, including pre-approval inspections
Developing and issuing quality metrics pertaining to the process quality activities
Reviewing and assessing deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
Reviewing Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
Supporting Quality Assurance to guide various projects and technical meetings, as needed
Qualification
Required
Must have knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing
Minimum of 5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry
Experience working with contract manufacturing organizations
Ability to provide project leadership and guide successful completion of Quality projects
Excellent written and verbal communication and negotiating skills
Risk assessment and risk management
Bachelor's degree required
Preferred
Experience working with gene therapy products preferred
Advanced degree a plus
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