MSAT Manager - Product Expert Chapter Lead

Job description

The Position

Job Summary:

• Responsible for safe, reliable, cost-effective and efficient operation of the experts network function in Manufacturing Science and  Technology (MSAT) department at RDSZ 
• Responsible to enable excellence in manufacturing by providing manufacturing technical support to the  production organizations that results in safe, compliant, high quality and continuously improving  production 
• Ensure ‘Right to Operate’ through compliance with all applicable GMP, SHE and other global and local  regulatory requirements as well as Roche’s Quality and SHE policies and standards 
• Lead a high performing team of product experts to work in close collaboration with the key functions R&D, Manufacturing, QC, QA, RA, BEAT to drive and ensure the successful phase-in and ramp up of the strategic RDSZ product portfolio consisting by 300+ Core Lab Immunochemistry and Clinical Chemistry assays, Core and  Pathology Lab system reagents (Roche core and non-core products) , PCR Media products, Tissue Dispenser products,point of care products.
• Partners and collaborate with scientists and technical experts across multiple site and Business Areas (e.g.  CPS, Tissue Diagnostics) for Technical Product Transfers, Design Transfers and product technical  investigations and product portfolio management related subjects 
• Early evaluation for new portfolio opportunities for Suzhou site and account for bring in strategic products portfolio by close collaboration cross multi functions, sites and business area

Accountabilities:

• Define and build the required capability for the expert network functions;
• Ensure required resources are available as needed;
• Build expert development system;
• Build scalable expert network (FTE, contractors, Roche expert network);
• Maximize synergies of available expertise and resources;
• Responsible for people development;
• Accountable for early evaluation for new product portfolio opportunities;
• Accountable for the feasibilities study for new products within approved portfolios;
• Accountable for the process validation of the products executed as planned;
• Accountable for the investigation and troubleshooting of the issues of the products as requested

Main Task & Responsibilities：

• Build product expert development system to develop the capability needed for the business;
• Expert Network resource planning:
• Seamlessly collaborate with product portfolio manager to ensure the resource are well planned for the business need for each product portfolio;
• Planning the resource for scale up and scale down with the dynamic business needs by leverage FTE, contractor;
• New product portfolio introducing evaluation
• Early technical feasibility evaluation for new product portfolio opportunities and provide the proper proposal to the corresponding stakeholders to final decision;
• Oversight the daily routine of the product experts team to ensure the assigned tasks are performed in time in compliance.
• Overall management of the document and process for the product engineers chapter.

Safety, Health & Environment 

• Proactively promote a safety culture; ensure that all applicable Safety, Health & Environment requirements  are fulfilled to comply with corporate group policy and local legal requirements 
• Leadership & People Management 
• Create an culture and environment of strong team spirit, high motivation and inspire teams to achieve  ambitious goals in short, mid and longer term 
• Motivate, engage employees and create followership toward common results. Leading change processes.
• Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• Ensure timely and effective communications 
• Establish strategic and ambitious goals in line with the RDSZ site value proposition and objectives
• Drive collaboration within site and across the network 
• Provides team members with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations
• Manage the department population towards the set headcount target 
• Recruit highly qualified people in a timely fashion 
• Exemplify the Roche Values and Leadership Commitments 

Quality and Compliance 

• Develops and drives a work culture committed to compliance and product quality
• Ensure ‘Right to Operate’ through compliance with all global and local regulatory requirements applicable  to RDSZ 
• Implement and apply the RDSZ Quality Management System (QMS) 

Product Supply 

• Maximize the service level to support uninterrupted supply of high-quality products

Cost Management 

• Ensure adequate budgeting for operating costs, headcount and CAPEX 
• Manage and control expenses and investments towards the set targets 
• Seek for continuous improvements in the department to optimize cost and enhance the department  productivity and competitiveness 

Continuous Improvement and Innovation 

• Establish and maintain a LEAN culture of continuous improvement that generates tangible contributions to  site operational performance 

General 

• Communicate and role model the Roche Strategic Framework including the Group Business Model and  the Group Management Model reinforcing the Roche values Integrity, Courage, Passion and motivate the  team to live them 
• Report activities and critical issues to superiors in a timely manner 
• Manage and optimize relationships with external authorities and communities in order to ensure a smooth cooperation 

Requirment

• A Bachelor’s degree in Science (e.g. Biological  Science, Biomedical or Chemical  Engineering)
• 10 or more years’ work experience in the  Diagnostic or other related industries
• Extensive experience of Diagnostic reagent  manufacturing processes, technical transfers  and investigation management
• Extensive experience in start-up and  validation of manufacturing equipment, clean  utility and process systems, including
• requirements for documentation and testing
• Knowledge of Roche internal and external  quality and regulatory requirements,  especially in professional Diagnostics
• Proven track record of consensus building  and conflict management in challenging or difficult situations

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.