The Project Manager for the Pharma team is responsible for planning, executing, and delivering technology-enabled projects within pharmaceutical operations including digital platforms, applications, automation initiatives, data systems, and compliance-driven IT solutions. The role ensures on-time delivery, stakeholder alignment, regulatory compliance, and continuous improvement of technology solutions supporting R&D, Manufacturing, QC, QA, Regulatory, and Supply Chain functions.
Key Responsibilities
- Define project scope, objectives, timelines, and deliverables for pharmaceutical technology applications
- Develop detailed project plans, schedules, resource allocations, and risk mitigation strategies
- Track progress using project management tools (e.g., MS Project, Jira, Azure DevOps, Smartsheet)
- Conduct requirement-gathering workshops with business users
- Facilitate communication among technical teams, vendors, and business stakeholders
- Oversee system design, configuration, testing (IQ/OQ/PQ), and deployment activities
- Ensure adherence to GxP, 21 CFR Part 11, data integrity, and audit-readiness requirements
- Maintain project documentation: URS, FRS, validation documents, project charters, test scripts, and SOP updates
- Manage project budgets, cost forecasts, and financial tracking
- Coordinate with external software vendors, integrators, and support teams
- Review SoWs, contracts, and vendor deliverables
- Identify project risks and implement mitigation strategies
- Lead issue resolution, change management, and impact assessments
- Prepare project dashboards, status reports, and executive presentations
- Ensure adherence to PMO standards and governance frameworks
Must Have Skills
- Project management tools (MS Project, Jira, Azure DevOps)
- Pharmaceutical applications (LIMS, ELN, QMS, MES, ERP)
- GxP compliance and 21 CFR Part 11
- Stakeholder management
- Documentation (URS, FRS, validation documents)
- Budget and vendor management
