Note: The job is a remote job and is open to candidates in USA. IT Advanz is hiring an SAP Project Manager to support a pharmaceutical client. The role focuses on planning and managing SAP implementations, ensuring pharmaceutical regulatory compliance and computer system validation, coordinating stakeholders and teams, and overseeing testing, integrations, budgets, vendors, and go-live activities.
Responsibilities
- Define project scope, objectives, deliverables, and success criteria
- Develop project plans, timelines, resource plans, and budgets
- Establish project governance structure and communication plans
- Manage project risks, issues, assumptions, and dependencies
- Lead steering committee and status review meetings
- Lead SAP implementations, rollouts, upgrades, migrations, or support engagements
- Coordinate end-to-end SAP delivery across functional and technical teams
- Ensure compliance with: FDA 21 CFR Part 11; GxP requirements; GMP (Good Manufacturing Practices); Good Documentation Practices (GDP); Data Integrity requirements
- Work closely with Quality Assurance and Validation teams
- Coordinate validation activities including: Validation Strategy; Validation Plan; User Requirement Specifications (URS); Functional Specifications (FS); Design Specifications (DS); IQ (Installation Qualification); OQ (Operational Qualification); PQ (Performance Qualification)
- Ensure all SAP changes are audit-ready
- Serve as primary interface between: Business teams; IT leadership; SAP consultants; Vendors; Quality and Compliance teams
- Communicate project status, risks, and mitigation plans
- Manage executive-level reporting
- Manage project budgets and forecasts
- Track actuals versus planned expenditure
- Control scope creep and change requests
- Monitor consulting partner and vendor invoices
- Lead onshore and offshore SAP teams
- Coordinate: Functional consultants; Technical consultants; Integration specialists; Validation resources; Testing teams
- Resolve conflicts and remove project roadblocks
- Identify project risks proactively
- Develop mitigation and contingency plans
- Escalate critical issues to leadership
- Monitor compliance and operational risks
- Oversee: SIT (System Integration Testing); UAT (User Acceptance Testing); Validation Testing
- Develop cutover and deployment plans
- Ensure successful go-live and hypercare support
- Coordinate integrations between SAP and: LIMS; MES; ERP systems; Manufacturing systems; Warehouse systems; Serialization platforms; Third-party logistics systems
- Support organizational change management initiatives
- Ensure user training materials are developed
- Coordinate end-user training sessions
- Drive user adoption and business readiness
- Manage SAP implementation partners
- Monitor SLA and project deliverables
- Conduct periodic performance reviews
- Ensure contract compliance
Skills
- Minimum Exp: 12+
- SAP S/4HANA implementation experience
- SAP Activate methodology
- SAP Solution Manager
- SAP ChaRM
- SAP ALM
- FDA regulations
- GxP compliance
- CSV validation
- GMP manufacturing processes
- Supply chain and serialization
- Agile and Waterfall methodologies
- Budget management
- Risk management
- Stakeholder management
- Executive communication
Benefits
- Remote work arrangement (USA profiles only)
- W2 employment contract
- Long-term contract
Company Overview