Project/ Program Manager

Role Summary:

We are seeking a Project Manager to lead end-to-end delivery of MES implementation, upgrades, and enhancement projects in a GxP-regulated pharmaceutical manufacturing environment. This role owns the integrated project plan, cross-functional execution, RAID, governance, change control, and project financial/resource tracking, ensuring delivery is on-time, inspection-ready, and compliant with applicable regulatory expectations (including CSV and 21 CFR Part 11 awareness).

• Own end-to-end project delivery for MES implementations, upgrades, and enhancements, including execution planning through hypercare/handover.
• Define and control scope: establish project objectives, deliverables, milestones, success criteria, and acceptance conditions with stakeholders.
• Build and maintain the integrated project plan (workstreams, dependencies, critical path, resourcing), and drive adherence across teams.
• Lead cross-functional execution across Manufacturing, Quality, Validation, Engineering, Automation/OT, IT, and vendors/partners to deliver committed outcomes.
• Own RAID management (Risks, Assumptions, Issues, Dependencies): proactively identify, quantify impact, drive mitigations, and escalate with clear options/recommendations.
• Run governance and stakeholder communication: steerco/operating reviews, project meetings, decisions, minutes/actions, and executive-ready status reporting.
• Own change control for project impacts: manage scope/timeline/cost changes, ensure approvals, and maintain decision traceability.
• Plan and coordinate testing execution: UAT and system testing planning with SMEs, defect triage cadence, prioritization, and closure of critical defects.
• Drive validation readiness in partnership with QA/Validation: ensure planning and delivery align to CSV lifecycle expectations and inspection-ready documentation standards.
• Track project financials and resources: budget estimates, forecasting, variance analysis, and capacity planning; highlight risks early and propose tradeoffs.
• Lead change management enablement: training coordination, readiness checkpoints, cutover/handover plans, and stabilization to operations/support.
• Vendor & partner management (as applicable) : manage timelines, deliverables, escalations, and performance against SOWs.

• Bachelors degree in Pharmacy, Life Sciences, Engineering, IT, or Business Administration (or equivalent experience).
• 8+ years of experience in project management / IT delivery / manufacturing systems within pharma, biotech, medical devices, or other regulated environments.
• Demonstrated ownership of integrated schedules, RAID, governance, change control, and delivery coordination across cross-functional teams.
• Working knowledge of pharmaceutical manufacturing fundamentals and the realities of shop-floor execution (deviations, batch operations, constraints).
• Practical understanding of SDLC (waterfall and/or Agile hybrid) and core PM disciplines (scope, schedule, cost, quality, comms).
• Strong documentation discipline and ability to produce audit-ready artifacts (plans, minutes, decision logs, traceability, status packs).
• Proficient with MS Office; experience with MS Project / Smartsheet / Jira strongly preferred.

• Experience delivering or supporting MES platforms such as Rockwell PharmaSuite, Werum PAS-X, Syncade, Camstar, Opcenter, etc.
• Experience with CSV concepts and deliverables (e.g., validation plans, requirements traceability, test protocols, summary reports) in GxP settings.
• Strong familiarity with GMP / GxP, data integrity, and 21 CFR Part 11 expectations (awareness level is acceptable; deep SME not required).
• Exposure to IT/OT interfaces, shop-floor connectivity, and manufacturing digital systems (e.g., LIMS, SCADA, historians, ERP integrations).

• Project Planning & Scheduling (critical path, dependencies, resource loading)
• RAID Management & Escalation
• Stakeholder Management & Executive Communication
• Governance & Status Reporting (SteerCo packs, decision logs)
• Change Control / Scope & Timeline Management