SAP Project Manager

IT Advanz is Hiring SAP Project Manager supporting a Pharmaceutical client, the role focuses on implementing, supporting, and optimizing quality processes in compliance with FDA, GxP, GMP, and other pharmaceutical regulatory requirements.

Role: SAP Project Manager

Location: Remote (USA Profiles Only)

Contract Type: W2 (Long term)

Minimum Exp: 12+

Key Roles and Responsibilities

1. Project Planning and Governance

• 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.

2. SAP Program Management

• Lead SAP implementations, rollouts, upgrades, migrations, or support engagements.
• Coordinate end-to-end SAP delivery across functional and technical teams.

3. Pharma Regulatory Compliance

• Ensure compliance with:
• FDA 21 CFR Part 11
• GxP requirements
• GMP (Good Manufacturing Practices)
• Good Documentation Practices (GDP)
• Data Integrity requirements

o Work closely with Quality Assurance and Validation teams.

4. Computer System Validation (CSV)

o 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)

o Ensure all SAP changes are audit-ready.

5. Stakeholder Management

• 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.

6. Budget and Financial Management

• Manage project budgets and forecasts.
• Track actuals versus planned expenditure.
• Control scope creep and change requests.
• Monitor consulting partner and vendor invoices.

7. Resource and Team Management

• Lead onshore and offshore SAP teams.
• Coordinate:
• Functional consultants
• Technical consultants
• Integration specialists
• Validation resources
• Testing teams
• Resolve conflicts and remove project roadblocks.

8. Risk and Issue Management

• Identify project risks proactively.
• Develop mitigation and contingency plans.
• Escalate critical issues to leadership.
• Monitor compliance and operational risks.

9. Testing and Cutover Management

• Oversee:
• SIT (System Integration Testing)
• UAT (User Acceptance Testing)
• Validation Testing
• Develop cutover and deployment plans.
• Ensure successful go-live and hypercare support.

10. SAP Integration Management

Coordinate integrations between SAP and:

• LIMS
• MES
• ERP systems
• Manufacturing systems
• Warehouse systems
• Serialization platforms
• Third-party logistics systems

11. Change Management and Training

• Support organizational change management initiatives.
• Ensure user training materials are developed.
• Coordinate end-user training sessions.
• Drive user adoption and business readiness.

12. Vendor and Partner Management

• Manage SAP implementation partners.
• Monitor SLA and project deliverables.
• Conduct periodic performance reviews.
• Ensure contract compliance.

Typical Skills preferred

SAP Skills

• SAP S/4HANA implementation experience
• SAP Activate methodology
• SAP Solution Manager
• SAP ChaRM
• SAP ALM

Pharma Domain Knowledge

• FDA regulations
• GxP compliance
• CSV validation
• GMP manufacturing processes
• Supply chain and serialization

Project Management Skills

• Agile and Waterfall methodologies
• Budget management
• Risk management
• Stakeholder management
• Executive communication

Thanks & Regards

Yogesh Jagtap

Recruitment Lead

Email: [email protected]

www.itadvanz.com