Instrument & Software Validation Compliance Lead, Clinical QC, Analytical Development & Clinical QC

Alexion • New Haven, CT

7d

About The Position

This is what you will do: The Instrument and Software Validation Compliance Lead in Clinical QC - ADQC will partner with IT Validation and support to drive the end-to-end validation lifecycle for Clinical QC laboratory instruments, control/acquisition software, and supporting digital platforms, ensuring systems remain in a validated state, compliant with cGxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and Alexion | AstraZeneca Rare Disease procedures. The Compliance Lead will lead planning, risk assessment, protocol development, execution, and documentation for instrument qualification (IQ/OQ/PQ) and computerized system validation (CSV) and will standardize and maintain validation deliverables using Val Genesis—including authoring and executing test scripts within Val Genesis to drive traceability and inspection readiness. The role partners closely with PDCS, QA, IT/IT QA, Clinical QC Operations, and external vendors. You will be responsible for: Validation Strategy & Governance: 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. Val Genesis Test Scripting & Execution: 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. Instrument Qualification Lifecycle: 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. Software CSV Lifecycle: 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. Data Integrity Controls: Implement and verify access controls, roles/SoD, audit trails, backups/restore, time synchronization, and disaster recovery testing; conduct periodic reviews and data integrity assessments. Documentation Excellence: 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. Change, Deviation, and CAPA Management: 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. Audit/Inspection Readiness: Prepare evidence, defend validation rationale, and support internal audits and health authority inspections; address observations with robust remediation. Vendor/Supplier Qualification: Partner with IT/QA/Procurement to assess and qualify instrument and software suppliers; review vendor SDLC and qualification packages; manage service agreements and certificates. System Administration Coordination: Work with IT/IS and system owners on configuration management, patching, upgrades, cybersecurity controls, and maintaining the validated state post change. Training & Enablement: Create training materials and train QC staff on validated instrument/software use, ValGenesis workflows, and data integrity practices; ensure training compliance. GMP Operations Support: Ensure validated systems support clinical stability, inventory, sample management, gLIMS data entry, certificate generation (CoA/CoT), and QC testing workflows. Continuous Improvement: Apply risk-based validation and Lean Six Sigma to streamline qualification/CSV, reduce cycle time, and strengthen controls; monitor validation effectiveness KPIs. Cross-Functional Representation: Represent Clinical QC-ADQC on technology/digital projects and provide technical validation input across PDCS and Clinical Supply. Global role requiring domestic and international travel (up to ~5%). Perform other related duties as assigned.

Requirements

• 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.
• As typical of an office-based role, the individual must be able, with or without accommodation, to use a computer; communicate via phone, video, and electronic messaging; engage in problem solving and collaboration; maintain availability during standard core business hours.

Nice To Haves

• 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.

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.
• Perform other related duties as assigned.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees