Head of Methods and Support Manufacturing

Location: Switzerland - Meyrin/Geneva

Division: Manufacturing/Production

Company: OM Pharma

Amina Oumeziane

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About You

In view of our continued global growth, we are looking for our new Head of Methods and Support Manufacturing in Meyrin/Geneva. 

Reporting to the Manufacturing Director, your main missions are: 

Activities support to the business units in Manufacturing department
- Maintain GMP standards and utilization of industrial assets
- Ensure operational activities execution with respect to GMP – regulatory files and SOPs in place
- Ensure up to date quality documentation – deviation management – Root cause analysis if applicable – CAPA Management for manufacturing units
- Realize defined reporting for Manufacturing Department (Monthly Report & KPIs) and adapt it if necessary
- Realize budget process for methods and support manufacturing and take appropriate measures if necessary
- Collaborate with all manufacturing  units in order to realize draft of SOP 
- Collaborate with Tech Engineering in order to define Program Technical Projects realization / CAPEX Management to support increased capacity and performance
- Collaborate with Maintenance team / QM in order to define efficient Maintenance Programs stop in accordance with production plans
- Ensure that Environmental Management System, Computerized Maintenance Management System  are well managed by manufacturing team and manage necessary improvements
- Ensure that Operational Excellence standards are well established, particularly 5S, Visual Management, and waste management mindset

Coordination of the correct application of the Quality framework within the Manufacturing department
- Guarantee the conformity of products, respecting the procedures in force, while making employees aware of the usefulness of respecting them
- Enforce the department's quality and safety rules, and control their application
- Collaborate closely with the various Quality departments
- Organize and control production operations in accordance with procedures and operating methods
- Manage CAPA and Deviations
- Document, finalize and verify batch files
- Participate in document management (updating and drafting of procedures)
- Check the qualification of people and equipment
- Define improvements in quality and productivity

Coordination of the implementation of continuous improvement within the Manufacturing department 
- Use and implement approaches and tools for optimizing the performance of industrial processes (Lean manufacturing, DMAIC approach, Six Sigma, Kanban, SS, Kaizen, workstation ergonomics, etc.)
- Diagnose and analyze the performance of existing production systems
- Follow production activities in the ERP 
- Capitalize on continuous improvement benchmarks (principles and methodology) 
- Identify and prioritize issues
- Suggest continuous changes to facilitate work organization and improve productivity 
- Participate in the design of an improvement plan for existing processes 
- Lead working groups and improvement proposals
 - Propose adapted and realistic solutions to improve systems by redesigning or modifying management methods 
- Implement continuous improvement recommendations 
- Review and adapt the organization of work and teams management 
- Define and monitor performance indicators and dashboards 
- Monitor the implementation of performance and efficiency improvements of equipment

API Manufacturing management, in the absence of the Head of API Manufacturing 
- Coordinate the smooth running of operational activities
- Inform and report to the Head of Manufacturing
- Ensure the operational interface between the team leaders and the Head of Manufacturing
- Perform PO management activities in the ERP
- Develop as a successor crash to the Head of API Manufaturing

Safety, Health and Environment activities management 
- Know and apply the company regulations regarding occupational Safety, Health protection and Environment 
- When needed, use safety devices and personal protective equipment appropriately
- Report immediately accidents and/or near misses to the Safety, Health and Environment Manager and to the line manager

To carry out these tasks the ideal candidate will have the following skills:
- Pharmacist and / or engineer in the biotechnological or industrial pharmaceutical field
- 10 years of professional experience in the biotechnology or industrial pharmaceutical field
- Proven experience in managing a method and production support team
- Confirmed experience of Quality systems (Processes, deviations, investigations, CAPA)
- Knowledge of working in a GMP environment
- Master the main quality improvement methods and techniques (Lean manufacturing, DMAIC approach, Six Sigma, Kanban, SS, Kaizen, ergonomics of workstations ...)
- Have an excellent vision of the business processes of the company and the supply chain
- Master the statistics applied to management, the technical aspects of manufacturing and the production apparatus and techniques related to quality projects.
- Operating experience of ERP, EMS, and CMMS, statistical tools and data processing from ERP
- Microsoft Office, Outlook, Trackwise, LMS experience
- Full fluency in French and very good written knowledge of English are a must

You are a dynamic and hands-on person, who likes to work in manufacturing environment. You can assess situations quickly and take decisions autonomously. 
If this sounds like you please do apply to this new position with us at OM Pharma in Meyrin/Geneva.

About Us

OM Pharma is a global Geneva-based Biotech company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams.
The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances.
For more information, please visit: ompharma.com.

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