Product Leader (f/m/d)

Product Leader (m/w/d)- Life Science / Engineering /German/medical device /project leading

Project / Role:
For our client Roche Diagnostics International AG in Rotkreuz we are looking for a highly motivated and qualified Product Leader (m/w/d)

Background:
The team of around 20 highly motivated Product Leaders that maintain over 45 products produced by Instrument Operations Rotkreuz or by selected OEM Partners along the entire product life cycle, from the early concept drawing through pilot and series production till the market phase out.
Therefore, some Products Leaders are involved in development projects of new products assuring the implementation of Operations requirements and aspects including Design for Quality and Manufacturability (DQM) and Cost of Goods Produced (CoGP) targets. Others are involved in all technical aspects of a product and its continuous cost optimization in the post launch product care phase.

A central element to manage this broad span of complexity are the so-called Product Teams, which are led by the Product Leader. This cross-functional platform enables timely and close collaboration with all involved functions including Development, Quality, Global Customer Service (GCS), Case, Investigation & Resolution Unit (CIR), Regulatory Affairs and Global Supply Chain. As member of the Product Care & Quality Team (PCQT), the Product Leaders reports to the PCQT Head and is in regular contact with the Operations Functional Leads and the Business Area.

Tasks & Responsibilities:
– Responsible for setup and leading the cross-functional Product Team
– Initiation of Product Care projects & activities; responsible for all underlying project management activities including planning (time, cost incl. CAPEX/PQ & PI budgets, resources, quality), delivery of underlying work results, monitoring and tracking, reporting, alignment with involved Functions within & outside Operations
– Leads the Product Care Budget Planning- & Alignment Process according to PCQT- (PQ-part) and Operations (PI-part) guidelines, responsible for budget monitoring
– Drives the SMC (Standard Manufacturing Costs) optimization process for his/her products, develops & aligns jointly with Production, Technical Support, Logistics Support, Strat. Procurement best possible solutions in respect to costs, manufacturability, testability, logistics; takes the Total Cost of Ownership for Roche into consideration (incl. service costs & complaint RCA)
– Responsible for implementation of CAPA process according to QMS requirements
– Responsible for blocking of non-conform products according to QMS requirements
– Responsible for implementation of Change Management Process according to QMS requirements
– Responsible for implementation of DQM (Design for Quality & Manufacturability) for his/her products within the given environment & life cycle stage
– Defines and tracks with his/her Product Team the yearly cross-functional Product Care objectives (incl. TAT, MTBRV, Right first time (RFT), Spare Parts Costs, ProCare Budget), aligns these with impacted Functions & Stakeholders
– Responsible for the continuous Product Risk Management Process and resulting updates to the Risk Management File during the Post Launch phase until product phase out
– Responsible for the Risk Assessment of the instrument manufacturing processes (process-FMEAs) in close cooperation with the responsible Head of Production & Production Team Leads
– Representation of Global Operations in the R&D project teams
– Leads the Product Problem Meetings (PPM) on request, acts as interface between PPM and Product Team
– Contact to Operations Functional Leads for all Product Lifecycle Management activities
– Member of the responsible PCQ Team (Product Care & Quality)
– Supports demand planning in close alignment/cooperation with BA-PCQT, Logistics, Production, potentially Affiliates for his/her product
– Creation and tracking of supplier engineering change requests with involved internal Functions and external partners
Execution of technical content reviews (incl. risk assessment, need & quality of underlying documentation for verification & validation) with external partners (suppliers, development partners)
– Supports the continuous improvement of the Roche end customer experience

Must Haves:
Academic degree in Life Sciences or Engineering, PhD and/or MBA of advantage
At least 3 years of professional experience in Medical device environment within a producing company
At least 3 years of professional experience in a highly regulated environment and with regulatory affairs.
Experience in Projectmanagement: participation as well as project leading or subproject leading
Experience within a matrix organization
Fluent in spoken and written English and German is required
Experience in serial interface communication of advantage
strategic thinker, who provides clarity and focus on the key priorities
Can organize/manage his/her own work
Openness to take up new tasks, ability to delegate / to let go; willingness to proxy department head on a need basis
Courage to speak up, standing in case of cross-wind
Has very good communication & presentation skills (acts as role model)

Reference No.: 920112SGR
Role: Product Leader
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Start: 01.04.2021
Duration: 12++
Deadline: 08.03.2021