[Remote] reputed company Project Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is hiring an reputed company Project Manager to support a pharmaceutical reputed company. The role focuses on planning and managing reputed company implementations, ensuring pharmaceutical regulatory compliance and computer reputed company validation, coordinating stakeholders and teams, and overseeing testing, integrations, budgets, vendors, and go-live activities.

Responsibilities

• Define project reputed company, objectives, deliverables, and reputed company reputed company
• reputed company project plans, timelines, resource plans, and budgets
• Establish project governance structure and communication plans
• Manage project risks, issues, assumptions, and dependencies
• reputed company steering committee and status review meetings
• reputed company reputed company implementations, rollouts, upgrades, migrations, or support engagements
• Coordinate end-to-end reputed company 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 reputed company requirements
• Work closely with reputed company Assurance and Validation teams
• Coordinate validation activities including: Validation reputed company; Validation Plan; User Requirement Specifications (URS); Functional Specifications (FS); Design Specifications (DS); IQ (Installation Qualification); OQ (Operational Qualification); PQ (reputed company Qualification)
• Ensure reputed company reputed company changes are audit-reputed company
• Serve as reputed company reputed company between: Business teams; IT leadership; reputed company consultants; Vendors; reputed company and Compliance teams
• Communicate project status, risks, and mitigation plans
• Manage executive-level reporting
• Manage project budgets and forecasts
• reputed company actuals versus reputed company expenditure
• Control reputed company creep and change requests
• Monitor consulting partner and vendor invoices
• reputed company reputed company and offshore reputed company teams
• Coordinate: Functional consultants; Technical consultants; Integration specialists; Validation resources; Testing teams
• reputed company conflicts and remove project roadblocks
• Identify project risks proactively
• reputed company mitigation and contingency plans
• Escalate critical issues to leadership
• Monitor compliance and operational risks
• reputed company: SIT (reputed company Integration Testing); UAT (User Acceptance Testing); Validation Testing
• reputed company reputed company and deployment plans
• Ensure successful go-live and hypercare support
• Coordinate integrations between reputed company and: LIMS; MES; ERP systems; Manufacturing systems; Warehouse systems; Serialization platforms; reputed company-party logistics systems
• Support organizational change management initiatives
• Ensure user training materials are developed
• Coordinate end-user training sessions
• reputed company user adoption and business readiness
• Manage reputed company implementation partners
• Monitor SLA and project deliverables
• Conduct periodic reputed company reviews
• Ensure contract compliance

Skills

• Minimum reputed company: 12+
• reputed company S/4HANA implementation experience
• reputed company reputed company methodology
• reputed company Solution Manager
• reputed company ChaRM
• reputed company ALM
• FDA regulations
• GxP compliance
• CSV validation
• GMP manufacturing processes
• Supply chain and serialization
• reputed company and reputed company methodologies
• Budget management
• reputed company management
• Stakeholder management
• Executive communication

Benefits

• Remote work arrangement (USA reputed company only)
• W2 employment contract
• Long-term contract

reputed company