Quality Assurance Senior Specialist

Senior Quality Assurance Specialist

We are seeking an experienced Senior Quality Assurance Specialist – to support SAP S/4HANA transformation initiatives and implementation across complex enterprise environments.

The ideal candidate will bring strong QM module knowledge, project management experience, Quality Assurance process understanding, ERP implementation knowledge, and the ability to coordinate cross-functional teams through design, build, testing, deployment, and stabilization.

This role will partner closely with Quality Business Process Owners, functional SMEs, DTI, system integration partners, and business stakeholders to ensure SAP S/4HANA program activities are planned, tracked, communicated, and executed effectively.

The QA Senior Specialist will play a critical role in driving business alignment, support testing, ALM review and approvals, issue resolution, decision management, readiness planning, and successful adoption of future-state processes.

Key Responsibilities:

• Lead Quality Assurance (QA) business activities for the design, implementation, testing, testing approvals, deployment, and stabilization of the SAP S/4HANA Quality Management (QM) module within a regulated manufacturing environment.
• Serve as the Quality business lead back-up and SAP QM subject matter expert, partnering with Quality Business Process Owners, site Quality organizations, SAP functional teams, DTI, Validation/Computer Software Assurance (CSA), and implementation partners to translate Quality and regulatory requirements into scalable SAP QM solutions.
• Lead SAP QM fit-to-standard and solution design activities across core Quality processes, including incoming material inspection, in-process inspection, finished product inspection, inspection at goods receipt, stock transfer and other relevant inspection scenarios.
• Define business requirements and design decisions for SAP QM inspection processing, including inspection types, inspection lot creation and processing, inspection plans, master inspection characteristics, sampling procedures, results recording, defects recording, usage decisions, and quality stock disposition.
• Partner with Master Data teams to define Quality master data ownership, creation and approval processes, data standards, migration rules, cleansing requirements, mapping, transformation, load validation, and post-migration verification.
• Ensure appropriate integration of Quality inspection and inventory processes, including goods receipt inspection, Quality Inspection stock, blocked/restricted stock, inspection lot processing, usage decision, stock posting, material movement, batch status, and disposition.
• Define Quality requirements associated with batch-managed materials, including batch characteristics, classification, inspection results, batch status, shelf-life considerations, and Quality-related release and disposition controls.
• Review functional specifications, configuration documentation, process flows, user requirements, functional requirements, interface requirements, reports, forms, workflows, and technical design documentation to ensure alignment with approved Quality business requirements.
• Partner with DTI and technical teams to define and verify QM interfaces and integrations with manufacturing, laboratory, warehouse, serialization, document management, reporting/analytics, and other Quality systems, as applicable.
• Lead and support QA business participation in end-to-end testing and validation of SAP QM functionality, including System Integration Testing (SIT), User Acceptance Testing (UAT), regression testing, interface testing, negative testing, role/authorization testing, and business process qualification.
• Lead Quality defect triage and resolution by assessing SAP QM defects for business and compliance impact, determining appropriate prioritization, supporting root-cause analysis, reviewing proposed solutions, and ensuring appropriate retesting and closure.
• Ensure SAP QM implementation activities comply with applicable GxP requirements, data integrity principles, electronic records/electronic signature requirements, internal Quality Management System requirements, and computerized system validation/assurance standards.
• Assess changes to existing Quality processes, SOPs, work instructions, forms, records, roles, and controls resulting from SAP QM implementation and coordinate required Quality documentation updates.
• Support SAP QM cutover planning and execution, including Quality master data migration, open inspection lots, Quality stock, batch status, transactional data, interfaces, user access, and other Quality-critical cutover objects.
• Define and assess Quality Go-Live readiness criteria and support Quality approval of deployment based on completion of testing/validation, defect resolution, data readiness, SOP readiness, training completion, access readiness, cutover execution, and applicable compliance requirements.
• Lead Quality support during Hypercare and post-Go-Live stabilization, including SAP QM issue triage, Quality impact assessments, defect prioritization, data/process reconciliation, root-cause investigation, corrective actions, and transition to steady-state support.

Required Qualifications:

• Bachelor's degree in Engineering, Life Sciences, Quality, Information Systems, Manufacturing, Operations Management, Business, or a related field.
• 10+ years of experience in Quality Assurance, Quality Systems, Quality Operations, Manufacturing Quality, ERP/Quality transformation, business process management, or related roles within a regulated environment.
• Demonstrated experience supporting SAP S/4HANA, SAP ECC, or other enterprise ERP implementations, with direct experience in SAP Quality Management (QM) business processes strongly desired.
• Strong understanding of end-to-end Quality business processes within regulated manufacturing, including incoming material inspection, in-process inspection, finished product inspection, results recording, defect management, usage decision, material/batch disposition, and Quality release processes.
• Experience defining and translating Quality business and regulatory requirements into SAP QM process designs, functional requirements, user requirements, business rules, acceptance criteria, test scenarios, and system controls.
• Working knowledge of SAP QM functionality and master data, including inspection types, inspection lots, inspection plans, master inspection characteristics, sampling procedures, results recording, usage decisions, catalogs/selected sets, and Quality-related material master settings.
• Strong understanding of SAP QM integration with related S/4HANA processes and modules, including Materials Management (MM), Production Planning (PP), Batch Management, Warehouse Management/Extended Warehouse Management (WM/EWM), Procurement, Manufacturing, and Inventory Management.
• Knowledge of computerized system validation and/or Computer Software Assurance (CSA) principles, including risk-based assessments, requirements traceability, testing, defect/deviation management, test evidence, approvals, and release readiness.
• Working knowledge of applicable GxP requirements, data integrity principles, electronic records/electronic signature requirements, and Quality Management System controls relevant to enterprise computerized systems.
• Demonstrated experience supporting end-to-end SAP or ERP testing activities, including System Integration Testing (SIT), User Acceptance Testing (UAT), regression testing, interface testing, defect triage, business acceptance, and Quality sign-off.
• Excellent communication, facilitation, and stakeholder management skills, with demonstrated ability to lead process design workshops, requirements sessions, testing discussions, and decision-making forums with both business and technical stakeholders.

Preferred Qualifications:

• Hands-on SAP S/4HANA Quality Management (QM) implementation experience as a Quality Business Process Lead, Business Process Owner, Functional Business SME, Quality Workstream Lead, or similar role.
• Strong knowledge of SAP QM inspection processes, including inspection lot creation and processing, inspection planning, results recording, defects recording, usage decisions, stock posting, Quality Notifications, and material/batch disposition.
• Experience with SAP QM master data design or any equivalent master data system application, including inspection plans, master inspection characteristics, sampling procedures, catalogs, selected sets, inspection types, and Quality-related material master data.
• Experience integrating SAP or any other ERP with laboratory, manufacturing, Quality, document management, or other GxP systems, such as LIMS, MES, eQMS, or similar platforms.
• Experience supporting ERP data migration, cutover, go-live readiness, hypercare, and post-deployment stabilization within a global S/4HANA transformation.
• Experience working with SAP/ERP system integrators, consulting partners, technical development teams, and global/site Quality organizations to deliver standardized enterprise Quality processes.

Must Have Skill Sets:

• Incoming Quality Assurance / Quality Systems Experience
• Experience with Incoming Quality activities, including raw materials, components, sampling, inspection, testing, and material disposition.
• Working knowledge of GMP requirements, specifications, deviations, and Quality documentation.
• SAP Quality Management (SAP QM) Knowledge or any other ERP system
• Hands-on experience with SAP QM processes or any other ERP system, preferably SAP S/4HANA, including inspection lots, results recording, usage decisions, material status, and Quality-related master data.
• Ability to support data review, issue investigation, testing, and troubleshooting of SAP Quality processes.
• Data Analysis & Advanced Excel Skills
• Strong proficiency in Microsoft Excel for managing and analyzing large datasets, including PivotTables, XLOOKUP/V