Alexion Pharmaceuticals, Inc. · 16 hours ago
Instrument & Software Validation Compliance Lead, Clinical QC, Analytical Development & Clinical QC
New Haven, Connecticut, United States of America
Full-time
Onsite
Mid, Senior Level
$110K/yr - $166K/yr
7+ years expAlexion Pharmaceuticals, Inc. is seeking an Instrument and Software Validation Compliance Lead in Clinical QC. This role involves driving the end-to-end validation lifecycle for Clinical QC laboratory instruments and software, ensuring compliance with regulatory standards and maintaining the validated state of systems.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Define and maintain the Clinical QC validation framework for instruments and software aligned to GAMP 5 and Part 11/Annex 11; contribute to or author elements of the ADQC Validation Master Plan
Configure requirements, develop and author risk-based test scripts and configuration/technical specifications, manage RTM traceability, and execute/record testing within Val Genesis; ensure electronic approvals, audit trails, and version control meet data integrity (ALCOA+) expectations
Lead and track IQ/OQ/PQ and periodic review/requalification for QC instruments (e.g., chromatography systems, plate readers, spectrophotometers, osmometers, subvisible particulate counters, pH meters, balances, device testing rigs, etc.), including vendor FAT/SAT (factory and site testing) and align with CQC compliance requirement for coordination, calibration, and maintenance integration
Validate control/data acquisition software, LIMS/ELN/ECMS integrations, and middleware/interfaces; oversee URS, risk assessments, supplier assessments, configuration specifications, Part 11/Annex 11 evaluations, data migration, and decommissioning
Implement and verify access controls, roles/SoD, audit trails, backups/restore, time synchronization, and disaster recovery testing; conduct periodic reviews and data integrity assessments
Author/review validation deliverables (URS, TS/CS/DS, RTM, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols and reports, Part 11 assessments, Periodic Review reports, Decommissioning Plans) within Val Genesis; maintain legible, complete records
Lead CSV/qualification impact assessments for changes to instruments, software, and configurations; author validation and implementation change controls (as assigned), investigate software/instrument related deviations and EQVs; define effective CAPAs and verify effectiveness
Prepare evidence, defend validation rationale, and support internal audits and health authority inspections; address observations with robust remediation
Partner with IT/QA/Procurement to assess and qualify instrument and software suppliers; review vendor SDLC and qualification packages; manage service agreements and certificates
Work with IT/IS and system owners on configuration management, patching, upgrades, cybersecurity controls, and maintaining the validated state post change
Create training materials and train QC staff on validated instrument/software use, ValGenesis workflows, and data integrity practices; ensure training compliance
Ensure validated systems support clinical stability, inventory, sample management, gLIMS data entry, certificate generation (CoA/CoT), and QC testing workflows
Apply risk-based validation and Lean Six Sigma to streamline qualification/CSV, reduce cycle time, and strengthen controls; monitor validation effectiveness KPIs
Represent Clinical QC-ADQC on technology/digital projects and provide technical validation input across PDCS and Clinical Supply
Qualification
Required
BS in Engineering, Computer Science, Chemistry, Biochemistry, Information Systems, or related discipline
7–10+ years of relevant experience in instrument qualification and CSV for GxP laboratories (or equivalent combination of education and experience)
In-depth knowledge of cGxP, GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity applied to laboratory instruments and software
Strong understanding of QC laboratory workflows, instruments, and control/acquisition software; experience integrating instruments with gLIMS/ELN/ECMS and managing interfaces/middleware
Hands on experience authoring validation deliverables and risk-based test scripts in Val Genesis, including RTM maintenance, electronic approvals, audit trail review, and periodic review scheduling
Ability to produce clear, accurate, and legible validation documentation and to present/defend validation strategies during audits; strong verbal and written communication
Demonstrate ability to troubleshoot instrument/software issues, analyze logs/audit trails, assess risks, and propose pragmatic solutions; capable of organizing work with minimal supervision and providing timely progress updates
Ability to follow written procedures, ability to follow verbal and written instructions, maintain validated state of equipment and instruments, and ensure adherence to company policies and legal regulations
Proven ability to work cross functionally with QA, IT/IS, QC Operations, PDCS, Clinical Supply, and external vendors
Preferred
Experience with Veeva Vault ECMS, ELN, gLIMS, Empower, Softmax Pro, Chromeleon, and instrument data management platforms
Familiarity with cybersecurity controls, patch/upgrade validation, disaster recovery testing, and cloud/SaaS validation approaches relevant to instrument software and data systems
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
BioWorld Financial Watch
2026-01-17
bloomberglaw.com
2025-12-20
Company data provided by crunchbase