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:
- 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 (e.g. 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.
Must Haves:
- 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 navigating ambiguity, resolving complex challenges, and serving as a decisive problem-solver to overcome technical obstacles efficiently.
- You are fluent in written and spoken English and German for conducting frequent presentations to global stakeholders.
Nice to haves:
- You have a Master's degree in a technical or business discipline.
- Ability to balance strategic portfolio goals (40%) with high-volume operational execution (60%).
- Successfully manage Squad budgets (OPEX/CAPEX) and SMC cost accounts to drive savings and efficiency.
- Possess a results-oriented mindset with the tenacity to act as the final decision-maker for prioritization and resolve technical roadblocks.
- Proven matrix leadership skills to empower 5-10 person squads and foster a culture of accountability and psychological safety.
- Demonstrated competence in dealing with ambiguity and solving complex, multifaceted problems effectively.
- Experience in IVD product development following design control, manufacturing and testing.
- Extensive knowledge of Process Management methodologies (Lean, Six Sigma, etc.) and in-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820 etc.
- Flexibility and willingness to travel globally to support external manufacturing networks (10-20%).
Reference Nr.: 925376
Rolle: Technical Product Lead
Industrie: Pharma
Location: Rotkreuz
Pensum: 90 - 100%
Start: 01.01.2027(01.02.2027)
Duration: 12++ Months
Deadline: 10/11/2026
If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions, or our attractive payroll-only program: +41 41 760 77 01.
About us:
ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.