Alexion Pharmaceuticals, Inc. · 1 month ago
Manager, Clinical QC - GMP Sample Management and Testing, Analytical Development & Clinical QC
New Haven - College Street
Full-time
Onsite
Mid, Senior Level
$110K/yr - $166K/yr
5+ years expAlexion Pharmaceuticals, Inc. is a company focused on pharmaceutical science, and they are seeking a Manager for Clinical Quality Control (GMP) Shipping, Receiving, Sample Management, and Sample Stability. This role involves leading a team to ensure compliance with GMP guidelines and overseeing the management of QC samples within a regulated environment.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Supervise, mentor, and develop staff engaged in GMP-compliant QC sample shipping, receiving, storage, and stability monitoring. Ensure ongoing training and competency in GMP policies, sample handling, and documentation requirements
Oversee all sample management and compendial testing (Appearance, pH, Osmolarity, sub-visible particle testing etc.) operations to ensure complete compliance with GMP, internal SOPs, and regulatory requirements (FDA, EMA, etc.). Lead the team through internal and external audits/inspections, investigate deviations, and ensure timely implementation of CAPAs
Manage and direct the shipping and receipt of Clinical QC samples/reference material, ensuring correct packaging, secure transit, accurate documentation, and compliance with environmental control (e.g., temperature) requirements. Hands-on experience with international sample shipping, customs documentation, and regulatory requirements for global operations
Implement and maintain robust sample tracking and inventory systems to guarantee sample integrity, traceability, and chain-of-custody throughout the process. Regularly review inventory, reconcile records, and ensure proper archival or disposal of samples
Oversee the management of sample stability studies, including planning, initiation, monitoring, documentation, and reporting in alignment with GMP and protocol requirements. Ensure prompt response to any storage excursions and accurate data recording for regulatory filings
Identify and implement opportunities for process optimization, efficiency improvements, and risk mitigation while maintaining GMP compliance. Support digitalization, automation, and adoption of new technologies in sample logistics
Act as liaison with Quality Assurance, Manufacturing, Analytical Labs, Supply Chain, and Logistics to coordinate QC sample movement, resolve issues, and align on project timelines. Ability to effectively communicate complex technical content to diverse audiences, including regulatory bodies
Oversee the selection and management of couriers and service providers, negotiate contracts as needed, and ensure service level agreements (SLAs) are met
Ensure accurate and timely reporting of inventory, sample disposition, stability data, and key operational KPIs. Provide data and support for regulatory submissions and product release
Qualification
Required
A successful candidate will have a BS Degree or Master's degree in a scientific field (e.g., Chemistry, Biology, Pharmacy) or equivalent
5+ years of experience with GMP environments and QC sample management, including proven leadership or management track record
Deep understanding of GMP, ICH, and country-specific regulatory requirements related to sample handling, shipping, and stability
Proficiency in Laboratory Information Management Systems (LIMS), inventory tracking, and Microsoft Office Suite
Strong problem-solving, organizational, and communication skills
Demonstrated ability to lead teams through audits and regulatory inspections
Preferred
Lean Six Sigma or Other Quality Certifications: Formal training or certification in Lean, Six Sigma, Kaizen, or similar methodologies for process improvement
Project Management Certification: PMP (Project Management Professional) or similar certification indicating strong project management skills
Experience with Digital Solutions: Proficiency with digital tools for sample management, automation, or laboratory digitalization (e.g., advanced LIMS, electronic batch records, barcoding solutions)
Cold Chain Logistics Expertise: Specialized knowledge and experience in cold chain management, cryogenic sample handling, or temperature-controlled shipping
Audit and Inspection Experience: Direct involvement with health authority inspections (FDA, EMA, MHRA, etc.) and experience preparing responses or managing remediation activities
Vendor/Supplier Management: Experience negotiating, managing, and auditing third-party logistics providers, couriers, biorepositories, or sample storage facilities
Change Control and Risk Assessment Skills: Expertise in managing change controls, performing risk assessments (FMEA, HACCP), or driving risk mitigation projects in a GMP environment
Excellent Data Analytics Skills: Strong ability to analyze operational and quality data, interpret trends, and present findings to senior leadership
Experience in Biologics or Advanced Therapies: Background working with complex modalities such as biologics, cell and gene therapy materials, or highly potent compounds
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
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
bloomberglaw.com
2025-12-20
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