SAP Project Manager

IT ADVANZ; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

IT Advanz is seeking an experienced SAP Project Manager to support a pharmaceutical client, focusing on implementing, validating, and optimizing quality processes in line with FDA, GxP, GMP, and GDP requirements.

The role requires coordinating cross-functional teams across business, IT, QA, and validation, ensuring timely delivery, regulatory compliance, and audit readiness for SAP programs, upgrades, and integrations. Remote work option for US profiles.

Qualifications

• Extensive experience leading SAP projects in pharma/biotech environments.
• Strong knowledge of FDA 21 CFR Part 11, GxP, GMP, GDP.
• Proven ability to manage budgets, timelines, and cross-functional teams.

Responsibilities

• Define project scope, plans, and success criteria.
• Lead end-to-end SAP implementations and upgrades.
• Coordinate validation activities and ensure audit readiness.
• Manage stakeholders and communicate risks and mitigation plans.
• Oversee testing, cutover, and go-live activities.
• Collaborate with QA, Validation, and IT leadership.

Skills

Project Planning

Governance

Stakeholder Mgmt

Budget Management

Resource Management

Risk & Issues

Quality & CSV

Regulatory Compliance

Tools

SAP

CSV Tools

LIMS

ERP Integration

Job description

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)

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 Plan
• User Requirement Specifications (URS)
• Functional Specifications (FS)
• Design Specifications (DS)
• 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
• Quality and Compliance teams
• Communicate project status, risks, and mitigation plans.

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

• 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
• 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.