Senior Manager, Application Development

- Execute CSV activities for SAP implementation, enhancement, upgrade, integration, and support projects.
- Participate in validation planning and determine validation requirements based on system criticality, intended use, GxP impact, and risk.
- Support preparation, review, and approval of validation deliverables such as: Validation Plan / Master Validation Plan inputs.
- GxP and system impact assessments.
- Computerized System Risk Assessments.
- User Requirements Specifications (URS).
- Functional and Design Specifications, where applicable.
- Requirements Traceability Matrix (RTM).
- Test plans, test scripts, test protocols, and test evidence.
- Installation, Operational, and Performance Qualification documentation, where applicable.
- Validation Summary Reports.
- Standard Operating Procedures and Work Instructions.

- Review SAP business and functional requirements to ensure applicable GxP, quality, regulatory, and data integrity requirements are adequately addressed.
- Ensure requirements are clear, testable, traceable, and appropriately linked to business and regulatory risks.
- Support risk-based validation and testing strategies to avoid unnecessary testing while ensuring adequate control of GxP-critical functionality.
- Review SAP configuration, custom developments, workflows, reports, forms, interfaces, conversions, enhancements, and integrations from a CSV/GxP perspective.
- Participate in SAP testing activities including: Functional testing.
- System Integration Testing (SIT).
- User Acceptance Testing (UAT).
- Regression testing.
- GxP/validation testing.

- Review executed test evidence for completeness, accuracy, traceability, objective evidence, and compliance with validation procedures.
- Ensure test deviations, incidents, and defects are documented, investigated, resolved, and appropriately assessed for GxP impact.
- Support validation of SAP interfaces with external or third-party applications and ensure appropriate controls for data transfer, reconciliation, error handling, and audit trail.
- Assess and document data integrity controls including ALCOA+ principles , audit trails, electronic records, electronic signatures, access controls, and record retention.
- Support evaluation of SAP roles, authorization controls, segregation of duties, and privileged access where relevant to GxP processes.
- Participate in SAP data migration validation including source-to-target mapping, data verification, reconciliation, completeness, and accuracy checks.
- Support assessment and validation of SAP master data and transactional data impacting regulated business processes.
- Participate in validation of applicable SAP modules/processes such as: Materials Management (MM).
- Production Planning (PP).
- Quality Management (QM).
- Plant Maintenance / Asset Management (PM/EAM).
- Extended Warehouse Management (EWM).
- Finance and Controlling where GxP relevance exists.
- SAP Fiori applications and workflows.
- SAP integrations and interfaces.

- Work with SAP functional and technical teams to ensure validation requirements are embedded throughout the system development lifecycle.
- Support change controls and perform GxP/validation impact assessments for SAP enhancements, configuration changes, patches, upgrades, and releases.
- Support periodic reviews of validated SAP systems to confirm continued validated state.
- Support incident, problem, deviation, CAPA, and change-management processes affecting validated systems.
- Assist in maintaining validation documentation throughout the system lifecycle and ensure controlled documentation is current and audit ready.
- Support system decommissioning and archival activities where required.
- Participate in internal audits, regulatory inspections, customer audits, and supplier audits involving computerized systems.
- Provide validation documentation and evidence during inspections and respond to auditor/inspector queries as required.
- Ensure validation activities comply with organizational SOPs, Quality Management System requirements, and approved project methodology.
- Coordinate with Quality Assurance for review and approval of validation documents and resolution of compliance observations.
- Support qualification and assessment of SAP vendors, System Integrators, cloud/service providers, and third-party technology suppliers where applicable.
- Promote standardized CSV practices and consistent validation methodology across SAP projects and geographical locations.
- Identify validation risks early and escalate gaps that may impact regulatory compliance, data integrity, testing, or project go-live readiness.

- Any bachelor's or master's degree from a recognized institution.
- SAP certification in any relevant functional or technical area is preferred but not mandatory.
- CSV, GAMP 5, Quality, ISPE, or regulatory compliance certification is advantageous.
- Experience with SAP S/4HANA , particularly Cloud Private Edition or large-scale global SAP transformation programs, is preferred.
- Experience in pharmaceutical manufacturing, quality, warehouse, supply chain, laboratory, or regulated business processes is desirable.