External Site Lead, Global External Manufacturing

About the role

As an External Site Lead, within our Global External Manufacturing Team, you will be pivotal in overseeing our partnerships with Contract Development and Manufacturing Organizations (CDMOs). The site lead will oversee all activities to ensure seamless manufacturing operations. Your technical expertise in assembly and packaging pharmaceutical and biologics will be crucial as you lead the process control strategy and execution at external manufacturing sites. You'll drive matrix teams to provide operational oversight, manage change controls, analyze scientific datasets, and ensure compliance with regulations. Your role is essential for aligning manufacturing objectives, enhancing efficiency, and fostering continuous improvements that bring value to the business. Collaborating across all levels and functions, you will ensure the delivery of high-quality manufacturing operations, fitting into the broader organizational structure.

Responsibilities

• Manage and oversee CDMO relationships with a focus on manufacturing execution.
• Provide technical and operational oversight for assembly, label and pack.
• Manage global change controls and deviations effectively.
• Drive, manage, and deliver technology transfers.
• Analyze scientific datasets to ensure robust process control strategies.
• Author and review site-specific Continuous Process Verification (CPV) reports.
• Develop and implement corrective actions and drive business process optimization.
• Lead continuous improvement initiatives to enhance efficiency, quality, and cost-effectiveness.
• Manage supplier relationship activities from contract negotiation to execution.
• Conduct business performance reviews and manage partner governance.
• Act as a primary engagement leader and actively monitor performance.

Requirements

• Bachelor’s degree in related field, preferably in Engineering discipline, and a minimum of 7 years of experience.
• Expertise in device assembly and/or label and packaging.
• Experience in Operations or Supplier Relationship Management.
• Knowledge of cGMP, FDA/EMA regulations, and Process Performance Qualification.
• Expertise in external CDMO management, governance, contracting, and relationship management.