Interim Manufacturing Leader: Build & Scale Medical Device Ops

Aurora Lifesciences; United Kingdom; Presencial; GBP 85.000 - 125.000; Jornada completa

Descripción de la vacante

Aurora Lifesciences is seeking an Interim Manufacturing Manager to establish and scale onsite production in a start-up medical device environment. You will lead the creation of processes, equipment, and workflows, ensuring quality, compliance, and cost-efficiency.

The role requires hands-on leadership, ERP implementation experience (SAP/Oracle/NetSuite), and collaboration with R&D, Quality, and Regulatory teams to enable smooth product transfer from development to manufacturing.

Formación

• Experience leading manufacturing in medical device start-up or early-stage growth.
• Track record of building high-performing teams in manufacturing.
• Hands-on ERP implementation and management in SAP, Oracle, NetSuite, or similar.
• Strong understanding of ISO 13485, FDA 21 CFR Part 820, and other medical device regulations.
• Experience in production planning, process validation, and lean manufacturing.
• Strong problem-solving and interpersonal skills.

Responsabilidades

• Oversee all onsite production activities to ensure quality, efficiency, and cost-effectiveness.
• Establish and maintain manufacturing processes, workflows, and equipment to meet demand.
• Recruit, train, and lead a multi-disciplinary manufacturing team.
• Foster a culture of accountability, safety, quality, and continuous improvement.
• Lead the selection, implementation, and integration of an ERP system to support manufacturing, inventory, and supply chain operations.
• Ensure ERP processes are aligned with regulatory requirements and production needs.
• Ensure manufacturing operations meet ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory standards.
• Collaborate with Quality and Regulatory teams to maintain compliance and readiness for audits.
• Plan and execute manufacturing scale-up activities to meet commercial demand.
• Drive process improvements to optimise throughput, reduce waste, and improve yields.
• Work closely with R&D, Quality, Supply Chain, and Engineering teams to ensure smooth product transfer from development to production.

Conocimientos

Leadership

ERP implementation

Regulatory compliance

Manufacturing operations

Lean manufacturing

SAP

Oracle

NetSuite

Herramientas

SAP

Oracle

NetSuite

Descripción del empleo

Aurora Lifesciences is seeking an Interim Manufacturing Manager to establish and scale onsite production in a start-up medical device environment. You will lead the creation of processes, equipment, and workflows, ensuring quality, compliance, and cost-efficiency.

The role requires hands-on leadership, ERP implementation experience (SAP/Oracle/NetSuite), and collaboration with R&D, Quality, and Regulatory teams to enable smooth product transfer from development to manufacturing.