Terumo Aortic are currently looking for a Director of Manufacturing Operations to join our Glasgow facility during an exciting time of growth and investment within the business. We are seeking a dynamic and experienced Director of Manufacturing Operations to lead our manufacturing team to new heights. The Director of Manufacturing Operations will provide strategic and operational leadership to our manufacturing team. This role is pivotal in driving continuous improvement, ensuring compliance with regulatory standards, and achieving key business objectives. The Director will foster a culture of mutual trust and respect while spearheading initiatives to enhance manufacturing processes and capabilities.

The key responsibilities of the role are:

Strategic Leadership:

• Develop and execute a manufacturing strategy aligned with long-term growth, profitability, and capability goals.
• Collaborate with cross-functional teams (HR, R&D, Quality, Regulatory, Supply Chain) to integrate manufacturing processes.
• Ensure manufacturing meets internal and external customer requirements for safety, quality, speed, and cost.

Operational and Tactical Leadership:

• Lead Manufacturing departments to achieve strategic goals.
• Manage manufacturing costs in line with P&L requirements.
• Track and report KPI’s for Manufacturing Departments.
• Develop annual department budgets and initiate corrective actions as needed.
• Oversee project/device transfers into full manufacturing.
• Maintain a safe working environment and lead the team to meet SQDIP goals.
• Oversee day-to-day operations of the manufacturing team.

Operational Excellence:

• Lead and coach daily Kaizen and problem-solving activities.
• Facilitate cross-functional Kaizen events and develop new Kaizen leaders.
• Champion lean manufacturing principles to foster a continuous improvement culture.
• Collaborate with engineering and quality teams to improve methods of manufacture.

Talent Development:

• Set goals and objectives to support business and team development.
• Lead, develop, and mentor managers, engineers, supervisors, and other professional staff.
• Manage the development pipeline for future company leaders.

Regulatory and Quality Compliance:

• Stay updated on FDA and ISO13485 regulations.
• Maintain a robust quality management system ensuring regulatory compliance.
• Address issues within the QMS promptly as evidenced by on-time completion of actions.

Environmental Health and Safety:

• Create a safety culture and ensure compliance with all EHS regulatory requirements.
• Conduct risk assessments, manage accidents, and address hazards.

The successful candidate will possess;

• Bachelor’s degree or equivalent experience in the industry.
• Experience leading a structured strategy deployment process.
• Project management and problem-solving skills (PDCA, DMAIC, 8D).
• Excellent oral and written communication skills.
• Proficiency in ERP software (SAP, Oracle, JD Edwards, etc.).
• Proven lean practitioner with a record of sustained improvement.
• Minimum 7 years in the biotechnology/medical device industry.
• At least 5 years’ experience in manufacturing management.
• Deep understanding of quality system regulations (ISO13485, 21CFR820).