As a Site Manager External Manufacturing Medical Devices you will be part of the External Manufacturing Organization that manages strategic, outsourced development, manufacturing and packaging solutions.
You will manage strategic supplier relationships from early stage development through to commercial supply for Roche / Genentech Medical Devices suppliers.
In this role you will be leading cross-functional governance teams with responsibility for supplier selection, execution of development activities, clinical and commercial supply, GMP, quality and compliance standards.
You will be accountable for monitoring quality, compliance and regulatory aspects. With the early involvement of External Manufacturing in development programs we will guarantee the evaluation and selection of technologies and suppliers capable of supporting long term commercial, high quality supply at competitive total cost into the Roche / Genentech network.
Principal accountabilities of the position will be :
Responsible for selection, implementation, management and decommissioning of development and commercial device suppliers in alignment with Device Development, Quality and Device Procurement.
Closely collaborate with and provide technical input to Device Procurement to support best, ongoing total cost of ownership (TCO) and most favorable conditions in development and supply agreements and related work orders.
Prepare and / or negotiate and maintain commercial requests (RFI, RFQ, RFP). Lead and / or contribute in developing and negotiating development & commercial contracts, project timelines, milestones, key requirements and financial agreements.
Analyze and understand Medical Device market trends
Lead and collaborate with broad cross-functional teams (Legal, Finance, Supply Chain, Quality, Development, Procurement) to achieve Roche / Genentech’s business, manufacturing, technical and quality objectives and performance goals for the business relationships.
Setup and manage operational governance and relationships with the device suppliers.
In collaboration with internal stakeholders ensure that expectations to suppliers are clear, reasonable and realistic and are properly communicated.
Build and maintain market-intelligence of the medical device and prefilled syringes industry and propose identified supplier innovations to the internal teams.
Proactively collaborate with internal key stakeholders in Device Development, Quality and Procurement in the definition of technology and supplier strategies for medical devices & drug delivery systems and ensure early involvement of External Manufacturing in technology selection activities.
Manage budgets and financial performance to ensure financial targets are achieved.
Act as Subject Matter expert within the company for development and manufacturing of devices.
Who you are :
You hold a BA or Master Degree in Life Sciences or Engineering
12+ years of relevant industry experience in the development and / or manufacturing of medical devices / drug delivery devices
Demonstrated ability to lead global cross-functional, cross-enterprise project teams with subject matter experts from Quality, Manufacturing Operations, Supply Chain, Product Development, Commercial and Legal
Experience of working in global matrix organizations across functions and cultures
Ability to travel in order to support supplier governance meetings or site management activities (15 %) both domestically and internationally
Fluent in English language written & spoken
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