Project Manager Pharmaceutical New Product Introduction

Project Manager New Product Introduction (NPI) & Launch Readiness

• Lead supply chain development activities for global new product introductions and major lifecycle management initiatives.
• Develop and execute end-to-end launch readiness plans aligned with regulatory submission, approval, and commercialization timelines.
• Partner with Regulatory Affairs to understand filing strategies, approval assumptions, and market authorization requirements to ensure supply readiness.
• Translate launch milestones into manufacturing, procurement, distribution, and inventory requirements.

• Coordinate supply chain activities required to support regulatory submissions, registrations, inspections, and product launches.
• Lead planning activities necessary to generate validation, process qualification, engineering, and registration batch data.
• Partner with Technical Operations, Manufacturing Sciences & Technology (MSAT), Quality, and Regulatory teams to establish manufacturing readiness.
• Support registration and qualification of new manufacturing sites, contract manufacturers, and distribution facilities.
• Ensure all supply chain activities comply with GMP, GDP, and applicable regulatory requirements.

• Develop supply strategies to support launch, growth, and lifecycle management objectives.
• Collaborate with procurement and planning teams to ensure timely availability of raw materials, packaging components, and finished goods.
• Assess manufacturing capacity requirements and identify potential supply risks.
• Lead distribution, storage, and transportation readiness assessments for global product launches.
• Drive contingency planning and risk mitigation activities across the supply network.

• Lead ERP and supply chain system setup activities required for product launches.
• Oversee creation and maintenance of material masters, SKU setup, BOMs, planning parameters, costing structures, and distribution network configurations.
• Partner with IT and business teams to ensure seamless integration across SAP, ERP, planning, quality, serialization, and distribution systems.
• Ensure accurate product data governance and system readiness prior to commercialization.

• Serve as the supply chain representative on cross-functional value chain teams.
• Lead and influence global teams across multiple functions without direct authority.
• Manage complex project plans, budgets, risks, dependencies, and critical milestones.
• Present supply chain readiness updates and recommendations to senior leadership.
• Drive alignment across Regulatory Affairs, Manufacturing, Quality, Procurement, Commercial, Supply Planning, Logistics, Finance, and IT teams.
• Identify opportunities to standardize and improve supply chain development processes, tools, and governance.
• Implement best practices to enhance launch execution, planning effectiveness, and operational efficiency.
• Support digital transformation initiatives within supply chain planning, logistics, and manufacturing operations.

• Bachelor's degree in Supply Chain Management, Engineering, Operations, Business, Life Sciences, or related field.
• 7+ years of experience in pharmaceutical, biotechnology, medical device, or regulated healthcare supply chain environments.
• Demonstrated experience supporting new product introductions, commercialization, technology transfers, or supply chain development initiatives.
• Strong understanding of end-to-end supply chain processes, including:
• Demand and supply planning
• Manufacturing operations
• Procurement
• Distribution and logistics
• Inventory management
• Quality and regulatory requirements
• Experience with SAP and enterprise ERP platforms.
• Proven ability to lead cross-functional teams and complex global projects.
• Excellent communication, stakeholder management, and influencing skills.

• Global supply chain experience within a matrixed organization.
• Experience supporting regulatory submissions, product registrations, and market launches across multiple geographies.
• Knowledge of GMP, GDP, validation, serialization, and commercialization requirements.
• Project Management certification (PMP, Prince2, or equivalent).
• APICS/ASCM certification (CPIM, CSCP, or equivalent).
• Experience with advanced planning systems, supply chain analytics, and digital supply chain solutions.