Senior Specialist, External Quality
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Job Location:
New Haven, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Position Summary:
The Senior Specialist for External Quality will be responsible with management support for providing oversight of quality activities associated with drug substance drug product and manufacturing processes to contract manufacturing organizations including technology transfers within the External manufacturing realm. The Senior Specialist contributes and supports the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Change Control Deviations and CAPAs. Performs all responsibilitiesin accordance withcompany policies procedures and regulations.
Principal Responsibilities:
Serving as Quality Assurance support and SME for Drug Substance Drug Product andmaintainingknowledge of industry standards and regulatory requirements to ensure all drug manufacturing storage and shipping activities are compliant
Providing oversight of GMP systems completed by CMOs 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 CMOs in compliance Preventive Maintenance Deviation Management and Change Control Programs as theyimpactAlexion
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 issuesin a timely mannerresulting from record reviews and deviation events
Reviewing contractor documents i.e. Batch records deviations and change controls to ensure that theycomply withAlexion 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 metricspertaining tothe process quality activities
Reviewing and assessing deviations; includes performing risk assessmentsparticipatingin root cause analysis investigations trackingfollow-upand 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
Qualifications:
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
Experience workingwith gene therapy products preferred
Education:
Bachelorsdegree.Advanced degreea plus.
Competencies:
Excellent interpersonal skills are as is the ability to communicate well both verbally and written.
High level technical skills including quality risk managementauditingand pharmaceutical manufacturing.Technical writing skills.
Date Posted
20-Jan-2026Closing Date
26-Jan-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:
Senior IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
Alexion is a global biopharmaceutical company focused on developing life-changing therapies for people living with rare disorders.
