Technical Product Lead - Consumables

Technical Product Lead - Consumables : External Manufacturing / OPEX / CAPEX / Product Lifecycle Management / Lean / Six Sigma / Product Documentation / ISO 13485 / IVDR / FDA 21 CFR part 820 / English / Deutsch Background: 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 the Technical Product Lead for consumables you will be fully accountable for the assigned product throughout its lifecycle, covering quality, supply, compliance, and cost management. In this role, you will ensure overall Squad / Product Team performance and manage product/ production risks and issues, while holding full accountability for the Squad budget (OPEX/CAPEX). 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:

Must Haves:

• You will maintain complete accountability for the assigned product across its lifecycle, including quality, supply, compliance, cost, risk management, product specifications, production process specifications, and product documentation.
• You will manage all product changes, complaints, deviations, and production assets, including equipment, spare part management, and the execution of operative risk management.
• You will develop and implement the product-wide production capacity plan in line with the Product Strategy, planning replacements and new investments, including the calculation of business cases.
• Manage the SMC cost account, including budget planning and identifying potential savings. Chair the Squad, provide necessary leadership, and act as the final decision-maker for prioritization, resource allocation, and conflict management.
• Manage and influence key internal and external stakeholders-including suppliers, subsuppliers, procurement, OPPM functions, business partners ( IPM), and the GSC-to align on demand forecasts and operational performance.
• Hold accountability for overall Squad performance and manage the comprehensive Squad budget, including OPEX, CAPEX, development, and PCQT budgets.
• Represent External Manufacturing in system development projects and within Business Teams at the PCQT level.
• Compile the Annual Product Review Report in collaboration with key stakeholders, identifying and triggering appropriate actions, risks, and mitigations.
• Chair operative-level Product Meetings with suppliers and sub-suppliers, maintain an understanding of supplier contract content, and monitor supplier safety stock and Roche hub stock against established targets.
• Develop production output reports in collaboration with relevant functions and report progress directly to the leadership team.
• Track demand forecast developments and fluctuations with business partners to trigger necessary follow-up actions.
• Foster a clear strategic prioritization and OneRoche mindset within the Squad, support team members in assuming their responsibilities, and provide performance feedback to the leadership team.
• You hold a Bachelor's degree in a relevant technical or business field such as Engineering, Natural Science, or Business Administration
• You have 1-3 years of product leadership experience, ideally within a matrixed environment
• You have a proven track record in Product Lifecycle Management (PLM), encompassing quality, supply, compliance, and cost management
• You have experience in External Manufacturing, including day-to-day supplier interaction and managing production risks and issues
• You have experience in Strategy and Capacity Planning, such as developing multi-year plans and calculating business cases for new investments.
• You have experience navigating In-Vitro Diagnostics (IVD) or medical device environments, ensuring adherence to strict regulatory and product documentation standards
• You excel at navigati