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

This is what you will do:

TheInstrument and Software Validation Compliance Leadin 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 withcGxP21 CFR Part 11EU Annex 11GAMP 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 usingVal Genesisincluding 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 toGAMP 5and Part 11/Annex 11; contribute to or author elements of theADQC Validation Master Plan.

Val Genesis Test Scripting & Execution: Configure requirements develop and author risk-based test scripts and configuration/technical specifications manageRTMtraceability and execute/record testing withinVal Genesis; ensure electronic approvals audit trails and version control meet data integrity (ALCOA) expectations.

Instrument Qualification Lifecycle: Leadand track IQ/OQ/PQand 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; overseeURS risk assessments supplier assessments configuration specificationsPart 11/Annex 11evaluations data migration and decommissioning.

Data Integrity Controls: Implement and verify access controls roles/SoD audit trails backups/restore time synchronization and disaster recovery testing; conductperiodic reviewsand 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 effectiveCAPAsand 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 supportclinical stability inventory sample management gLIMS data entry certificate generation (CoA/CoT) and QC testing workflows.

Continuous Improvement:Applyrisk-based validationandLean Six Sigmato 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.

You will need to have:

Education & Experience:

BS inEngineering Computer Science Chemistry Biochemistry Information Systems or related discipline

710 yearsof relevant experience ininstrument qualification and CSVfor GxP laboratories (or equivalent combination of education and experience).

Regulatory & Guidance Expertise: In-depth knowledge ofcGxPGAMP 521 CFR Part 11EU Annex 11 andALCOAdata integrity applied to laboratory instruments and software.

Laboratory & Technical Proficiency: Strong understanding of QC laboratory workflows instruments and control/acquisition software; experience integrating instruments withgLIMS/ELN/ECMSand managing interfaces/middleware.

Val Genesis Proficiency: Hands on experience authoring validation deliverables andrisk-based test scriptsinVal Genesis including RTM maintenance electronic approvals audit trail review and periodic review scheduling.

Documentation & Communication: Ability to produceclear accurate and legiblevalidation documentation and to present/defend validation strategies during audits; strong verbal and written communication.

Problem Solving & Ownership: Demonstrate ability to troubleshoot instrument/software issues analyze logs/audit trails assess risks and propose pragmatic solutions; capable of organizing work withminimal supervisionand providing timely progress updates.

Compliance Mindset: 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.

Collaboration: Proven ability to work cross functionally withQA 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.

We would prefer for you to have:

Experience withVeeva Vault ECMSELNgLIMS Empower Softmax Pro Chromeleon and instrument data management platforms.

Familiarity withcybersecurity controls patch/upgrade validation disaster recovery testing and cloud/SaaS validation approaches relevant to instrument software and data systems.

The annual base salary for this position ranges from $110000 to $166000. However base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

Date Posted

Closing Date

Our 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.