Director of Manufacturing Operations

MM Search are delighted to be working with Turemo Aortic on their new Director of Manufacturing Operations role

MAIN PURPOSE OF JOB AND OBJECTIVES:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. The director of manufacturing will provide leadership to the manufacturing team while managing personnel and processes involved in their assigned area of responsibility. The director is responsible for creating a culture of continuous improvement by developing people who are capable of problem solving to achieve strategic and business objectives. The position is based in the Glasgow facility.

Strategic Leadership
· Create and nurture an environment of mutual trust and respect between leadership and professional staff with associates at the Gemba.
· Develop and execute a manufacturing strategy to achieve key long-term growth, profitability, and capability goals.
· Collaborate with cross-functional teams to integrate manufacturing processes with other departments such as HR, R&D, Quality, Regulatory, and Supply chain.
· Ensure that manufacturing capability best supports internal and external customer requirements for safety, quality, speed, and cost.

Operational and Tactical Leadership
· Provide leadership to the Manufacturing departments to ensure consistent behaviours and progress to department strategic goals.
· Management of manufacturing costs ensuring that they track in line with Manufacturing P&L requirements
· Reporting and tracking of all KPI’s for Manufacturing Departments in line with business goals
· Assisting in the development of annual department budgets to meet sales forecasts including initiating corrective actions where required
· Supporting the transfer of projects/devices into full manufacturing
· Provide a safe working environment for all associates.
· Lead the team to meet Safety, Quality, Delivery, Inventory, and Productivity goals (SQDIP).
· Ensure an effective site daily management system is in place.
· Oversee the day-to-day operations of the manufacturing team.

Operational Excellence
· Lead and coach daily Kaizen and problem solving and at the Gemba.
· Lead and facilitate cross functional Kaizen events and develop new kaizen leaders.
· Champion lean manufacturing principles throughout the organization, creating a continuous improvement culture.
· Seek new methods of manufacture to improve quality, reduce cost, improve efficiency or shorten cycle time in close collaboration with engineering and quality.

Talent Development
· Lead the teams ensuring goals and objectives are in place to support the business goals and progress both team and individual development delivering high performance Lead, develop, and mentor managers, engineers, supervisors, and other professional staff.
· Manage the development pipeline to provide for future leaders of the company.

Regulatory and Quality System compliance

· Stay knowledgeable in required FDA and ISO13485 regulations.
· Maintain a robust quality management system to support and improve product quality while ensuring regulatory compliance.

QUALITY REQUIREMENTS:
Ensure compliance with all quality systems regulatory requirements such as, but not limited to, ISO 13485, 21 CFR Part 820, MDSAP, MDD (93/42/EEC) and MDR (EU 2017/745)
Responsible for addressing issues within the QMS without undue delay as evidenced by on time completion of actions on the Single Action Tracker (SAT) EH&S REQUIREMENTS
Create a safety culture and safe working environment.
Ensure compliance with all Environmental Health and Safety regulatory requirements.
Provide recourse to meet Environmental Health and Safety goals.
Maintain defined organisation Environmental Health and Safety competencies.
Ensure related Risk Assessments are completed, accidents raised and action hazards.

QUALIFICATIONS & EXPERIENCE:
Competencies
· Applies business understanding.
o Technical leadership and demonstrated success in a broad range of core competencies applying specialized technical skills.
o High level of financial acumen including understanding of operations impacts to the income statement, statement of cash flow, and the balance sheet.
o SME in the application of cross-functional and external resources to departmental activities
o Subject matter expertise in QMS and other requirements

· Communicates effectively.
o Strong cross-functional communication leadership skills
o Preparation and delivery of effective presentations to Executive leadership o Effective organizational "presence" in communications

· Demonstrates customer focus.
o Provides organizational leadership in applying understanding of industry responsibilities to internal/external customers.

· Develop self and others.
o Demonstrated application of industry skills with defined subject matter expertise o Recognized mentor to lower positions.

· Drives improvement, innovation, and changes.
o Functionally recognized innovative thinking and relied upon to advance product or process opportunities and solve complex problems and challenges.
o Leads organizational change and improvement opportunities.

· Takes accountability for results.
o Completes individual and leads large project teamwork activities as assigned demonstrating ability to effectively manage overall productivity and deliver strong results.
o Develops effective objectives and executes approaches and timelines to meet or exceed them.

· Teamwork to achieve a common goal.
o Excellent leadership and communications skills with ability to organizationally collaborate effectively with others.

Minimum Knowledge & Experience Required for the Position:
· Bachelor’s degree or appropriately equivalent experience in the industry,
· Experience in leading a structured strategy deployment process.
· Ability to organize and manage projects and work independently.
· Demonstrated ability to analyse and solve problems using structured methods (PDCA, DMAIC, 8D).
· Excellent oral and written communication skills (English)
· Working knowledge of an ERP software such as SAP, Oracle, or JD Edwards, etc
· Proven lean practitioner with a track record leading sustained improvement,
· At least 7 years in a biotechnology/medical device industry
· At least 5 years’ experience in manufacturing management
· Deep understanding of quality system regulations (ISO13485, 21CFR820)