Project Manager, Validation & Product Transfer

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Project Manager, Validation & Product Transfer

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As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

The Project Manager is responsible for end-to-end planning, coordination, and execution management of a portfolio of site projects across process/product validation, product transfer (technology transfer), and validation/qualification work streams. The role partners with cross-functional stakeholders to ensure projects are delivered on time, within scope, and within budget, while maintaining a high standard of GMP documentation and inspection readiness.

This position supports lifecycle validation expectations (including process design, process qualification, and continued process verification) and execution of risk-based technology transfers consistent with recognized industry and regulatory expectations.

• Coordinate internal resources and cross-functional teams for the flawless execution of multiple concurrent projects (validation, product transfer, room transfers, technical services deliverables).
• Ensure all assigned projects are delivered on time, within scope, and within budget; maintain project baselines and controlled change management.
• Lead routine project governance: cadence meetings, action logs, decision tracking, and escalation pathways.
• Report project status, risks, dependencies, and recovery plans to management; elevate issues early to protect timelines and compliance commitments.

• Meet with site leadership and project sponsors to clarify project objectives, scope, and success criteria; keep projects aligned to site goals and business priorities.
• Assist in defining scope and objectives, involving all relevant internal stakeholders and ensuring technical feasibility.
• Build and maintain long- and short-term plans, including milestone targets, critical path, and resource forecasts.
• Manage changes to project scope, schedule, and cost using appropriate verification techniques; ensure impacts are understood and approved through the correct governance route.

• Perform risk management to minimize potential risks, including creation/maintenance of risk registers and mitigation plans.
• Make effective, timely decisions when presented with multiple options for progressing work; document decision rationale and resulting actions.
• Drive closure by aligning owners and due dates, tracking completion, and removing barriers.

• Manage relationships with site leadership and relevant stakeholders; maintain alignment across functions and shifts.
• Facilitate resource availability and allocation across competing priorities; proactively identify constraints and recommend options/tradeoffs.
• Delegate project tasks based on team members’ strengths, skill sets, and experience levels; ensure accountability for deliverables.

• Perform quality control throughout project execution to maintain expected standards (GMP documentation quality, completeness, traceability).
• Create and maintain comprehensive project documentation (project charters, plans, schedules, risk registers, meeting minutes, action logs, timelines).
• Develop comprehensive project plans to share with team members and stakeholders; maintain visibility dashboards and reporting.
• Track and analyze project performance using appropriate project management tools and techniques; measure…