Product Lead External Manufacturing (m/f/d) - IVD product Development and Management/ design control, manufacturing and testing /Leadership/ in-vitro diagnostic related regulations /German and English
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Project :
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Product Lead External Manufacturing.
Background :
Global External Manufacturing is the competence center for parts and products in the diagnostic workflow, manufactured by external suppliers. This includes the development of new products, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement..
The perfect candidate:
As Product Lead you are the focal point for your designated products and work in an interdisciplinary team ensuring a holistic view of necessary activities. In this position you have versatile and varied responsibilities interacting with our Suppliers, Supply Chain, Quality and Regulatory as well as System Development and Business Management ensuring continuous learning and development. Together with the team members you have the possibility to exercise your leadership, enfolding the swarm intelligence of the people surrounding you. The need to visualize complex interdependencies for fact based decision making, ensures ample opportunity to use your communication and presentation skills..
Tasks & Responsibilities:
• Accountable for assigned products
• Is accountable for Product- /Production-issues and risks
• Owner of product specification and production process specification
• Accountable for product changes, complaints and deviations
• Accountable for spare part management
• Accountable for production assets and equipment
• Accountable for the overall Squad performance with regards to quality, supply, compliance, cost
• Ensures a clear, strategic Squad view on prioritization and OneRoche mindset
• Develops and implements the product wide production capacity plan and output report in collaboration with the relevant functions in accordance with the Product Strategy and provides information to Network Lead
• Acts as the final decision maker within Squad e.g. prioritization
• Manages all key stakeholders at Squad level (internal and external)
• Represents Global External Manufacturing in Business Teams on PCQT level, represents Global External Manufacturing in system development projects
• Interacts with business (e.g. IPM) to understand demand forecast, its development and fluctuations and triggers follow up actions
• Compiles Annual Product Review Report in collaboration with all relevant stakeholders, including triggering actions, risks and mitigations
• Chairs Product Meeting with supplier and sub-suppliers at an operative level
• Chairs the Squad and provides necessary leadership to the team members to assume their responsibilities
• Responsible for Squad budget (e.g. OPEX/CAPEX, development budget, PCQT budget)
• Manages SMC cost