Team Coordinator Global Medical Device Management (m/f)
The Team Coordinator Global MDM works independently and leads Supplier Quality Oversight from Supplier selection / design development phase to post commercial phase for purchased medical devices, medical device components and constituent parts for Combination Products (collectively referred to as Medical Device direct materials hereafter).
• Lead Device Supplier Quality oversight activities in accordance with the applicable regulations, guidelines, GMP and Roche standards
• Evaluate and solve a wide range of complex issues that affect multiple functions / sites related to direct material discrepancies, market complaints and associated investigations, in accordance with the applicable regulations, guidelines, GMP and Roche standards
• Initiate, assess, and manage vendor initiated changes and third party actions for Roche initiated change in accordance with applicable regulations, guidelines, and Roche standards
• Perform audits of direct material suppliers according to the Supplier Quality Management Audit Program
• Monitor and Trend the performance and risk level of assigned Suppliers, Identify, Define and Implement Supplier corrective and improvement projects by proactively collaborating with Functions / Sites and Suppliers to enhance the quality and supply of direct materials
• Create and Negotiate Quality Agreements. Provide quality requirements and negotiate final Supplier Specification
• Participate in due diligence assessment for Supplier selection, Lead Supplier qualification and maintain its approved state through consistent satisfactory performance.
• Strive to meet company and department goals and metrics
• Drive continuous improvement objectives through end-to-end lifecycle management of processes and application of LEAN principles
Who you are:
• Master or university degree in engineering, pharmacy, life sciences or equivalent
• Additional qualification in cGMP or auditing
• at least 12 years of experience in pharmaceutical or medical device industry in the area of Quality Assurance, Quality Control, Production or Development, or an equivalent combination of education and experience in combination products, aseptic manufacturing and working in matrixed and global environments is preferred
• Hands-on experience in medical device manufacturing
• Demonstrated capability of applying risk management concepts and tools, and Design Control
• Sound knowledge of Pharma and Medical Device GMPs, ISO standards and applicable international regulations, including but not limited to, Quality Systems Regulations and EU Medical Device Directive, ISO 13485, ISO 14971, ISO 9001, 21CFR Part 4 and Part 820.
• Ability to interpret and apply Quality Standards related to Roche products and suppliers
• Understanding of primary container and drug product manufacturing processes, laboratory test methods to include EP, USP, JP requirements, and industry standards preferred
• Demonstrated teamwork, collaboration and influencing skills and relationship management with third parties, and ability to communicate clearly and professionally both verbally and in writing.
• Demonstrated problem solving and decision making skills including hands on working experience with basic statistical tools. Six Sigma / LEAN knowledge is preferred
• Knowledge in analytical methods, risk assessment and project management is beneficial
• Excellent in written and verbal communication and negotiation in a difficult and complex environment in English; German would be beneficial
• Responsible for setting own goals and tasks after discussions with superior
• Ability to lead a small group of people
• Manage a cross-functional team in a matrix structure (e.g. in an audit, material review board)
• Moderate effects on several departments or interests
Willingness to travel (up to 30% domestic and international travel)
Who we are:
With more than 12,000 employees Roche Diagnostics GmbH (RDG) represents the third largest site within Roche. Apart from the two sales organizations in Germany (Roche Pharma AG and Roche Diagnostics Deutschland) RDG is focused on the operative business. At the two sites in Mannheim and Penzberg new diagnostic tests and pharmaceutical active ingredients are developed and produced for the global market.
Roche is an equal opportunity employer.
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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