Head of Manufacturing

About the role

SciPharm, a specialist in implantable infusion products, is expanding rapidly and seeks a Head of Manufacturing to lead its Turnhout facility. You will be responsible for the overall performance of the manufacturing operation, ensuring compliance, quality, and continuous improvement.

Key responsibilities

• Provide strategic and operational leadership for production planning, capacity management and resource allocation.
• Lead, develop and motivate the manufacturing team, fostering a culture of quality and operational excellence.
• Ensure full compliance with FDA 21 CFR Part 820, EU MDR (2017/745) and ISO 13485, including process validation (IQ/OQ/PQ) and change control.
• Take accountability for manufacturing quality outputs, coordinating with QC, procurement and release activities.
• Drive Lean and Six Sigma initiatives to improve yield, cycle time and cost efficiency.
• Own the manufacturing part of the QMS, maintaining SOPs, work instructions and audit‑ready records.
• Manage supplier qualification, performance monitoring and audit activities.
• Collaborate on design transfer, provide manufacturability input and manage process changes under design control.
• Oversee budget, CAPEX planning and equipment lifecycle to keep the infrastructure fit for purpose.

Required profile

• Bachelor’s or Master’s degree in Engineering, Industrial Engineering, Manufacturing or related field.
• Minimum 8 years of experience in medical device manufacturing, with at least 3 years in a leadership role.
• Strong knowledge of FDA 21 CFR Part 820, EU MDR 2017/745 and ISO 13485 in a manufacturing environment.
• Proven track record in process validation (IQ/OQ/PQ) and formal change control.
• Experience applying Lean and Six Sigma methodologies; Green Belt certification is a plus.

Required skills

• FDA 21 CFR Part 820
• EU MDR 2017/745
• ISO 13485
• Process validation (IQ/OQ/PQ)
• Lean manufacturing
• Six Sigma
• Green Belt (optional)