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Product Lead External Manufacturing: IVD product management / ISO 13485 / IVDR / FDA 21 CFR / OPEX/CAPEX / German / English

Project:
For our customer a big pharmaceutical company in Rotkreuz we are looking for a highly 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 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 ( 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 ( 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 Operative Risk Management
• Plans replacements and new investments and calculates business cases
• Understands contracts with suppliers with regards of content
• Monitors the supplier safety stock and the Roche hub stock versus 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
• Ability to think strategically and systemically, willingness to try new ideas and participate in changes
• Leadership experience and skills, including the ability to get things done with a proven track record of consensus building and conflict management in challenging situations
• Self-motivated, autonomous, structured and goal-oriented 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 where you perform well under pressure and with decisiveness
• Excellent communication skills in German and English
• Travel required 10(-20)%

Nice to Haves:
• Experience in IVD product development following design control, manufacturing and testing
• Knowledge of Process Management methodologies (Lean, Six Sigma, etc.) and in-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820etc.

Reference Nr.: 924863SDA
Role: Product Lead External Manufacturing
Industrie: Medical
Workplace: Rotkreuz
Pensum: 90 - 100%a