Description
Senior Operations Product Leader (m/w/d) - CAPA/SCAR/travel /english/germanProject / Role:
For our partner client a big pharmaceutical company based in Rotkreuz we are looking for a highly motivated Senior Operations Product Leader
Background:
We are a 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.
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.
Our responsibilities
For R&D Projects (New Developments & Product Updates) and Transfer Projects
Leading the Operations sub-project team
Project leadership from concept to serial production in Operations Instruments
Responsible for delivery of prototypes and pilot instruments
Responsible for implementation of Design for Quality & Manufacturability (DQM)
and for Continuous Process Improvements (CPI)
Responsible for providing the project- & product-documentation according to the
product development process including Device Master Record (DMR)
For On Market Products (Product Care Phase)
Leading the cross-functional Product Team
Management and coordination of Product Care activities (triggered internally or from the field)
Driving the Product Care budget planning process & shared Product Care objectives
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, 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
* 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:
* Chemist, Biologist, Bio-Informatics scientist, degreed engineer
* 5 years' experience in Medical device environment
* Fluent in spoken and written English and German
* PhD and/or MBA preferred
Nice to Haves:
* Is a 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.: 919540SGR
Role: Senior Operations Product Leader
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Start: 17.08.2020
Duration: 12++