Consumables Owner

vor 1 Woche

Zug, Zug, Schweiz ITech Consult Vollzeit

Consumables Owner (M/F/d) - ISO 13485 /
FDA 21 CFR / Risk Management / English / German**
Project:For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Consumables Owner (M/F/d)

Background:
Global Operations Consumables is the competence center for single-use injection molded parts in the diagnostic workflow.

This includes the development of new consumables, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.

It has expertise in all injection molding and plastic-relevant areas: Mold technology, polymers, automation, product design, supplier management, injection molding technique, plastics technology and material sciences.


A Consumables Owner is the focal point for your designated products and works in an interdisciplinary team ensuring a holistic view of necessary activities.

In this position the consumables owner has versatile and varied responsibilities interacting with Suppliers, Supply Chain, Quality and Regulatory as well as System Development and Business Management ensuring continuous learning and development.

Together with the team members the person has the possibility to exercise leadership, enfolding the swarm intelligence of the people surrounding.

The need to visualize complex interdependencies for fact based decision making ensures ample opportunity to use communication and presentation skills.


Tasks & Responsibilities:

  • Accountable for assigned product(s)
  • 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 w/r 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 Consumables in Business Teams on PCQT level, represents Consumables 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 subsuppliers at an operative level
  • Chairs the Squad and provides necessary leadership to the team members to assume their accountabilities
  • Responsible for Squad budget (e.g. OPEX/CAPEX, development budget, PCQT budget)
  • Manages SMC cost account including budget planning and search for potential savings
  • Provides feedback to Chapter Leads on Squad Members
  • Executes Operatives Risk Management
  • Plans replacements and new investments and calculates business cases
  • Understands contracts with suppliers as regards of content
  • Monitors the supplier safety stock target and in Roche hub targets
  • Owns and maintains product documentation during Product Life Cycle

Must Haves:

  • University degree in Engineering, Natural Science or related disciplines
  • Min. 3 years of work experience in IVD product management and production engineering
  • Knowledge of Process Management methodologies (Lean, Six Sigma, etc.) and invitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820 etc.
  • Experience in IVD product development following design control, manufacturing and testing
  • Leadership skills including the ability to get things done with a proven track record of consensus building and conflict management in challenging situations, eg. in a project leader role
  • Ability to think strategically and systemically, willingness to try new ideas and participate in changes
  • Selfmotivated, autonomous, structured and goaloriented mindset with a solution oriented balance of short term mitigation and long term solution
  • Ability to effectively communicate with all levels of the organization by establishing credibility and building rapport
  • Executive presence, performing well under pressure and decisiveness
  • Excellent communication skills in English and min. good communication skills in German
  • Travel required 1020%

Nice to have:

  • First professional experience in Supply Chain Management/ Procurements as an interface
  • Experience in a highly regulated production environment (clean room facilities)
  • Experience with the design, construction and commissioning of highly automated production plants

Reference Nr
:

922638TP

Role:

Consumables Owner (M/F/d)
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