Roche
StrategicQualityPartner
“Strategic Quality Partner at Roche. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, compliance, product quality. acts as a single point of contact within project teams (New product development / Product Change) for a portfolio of products assigned to them. leads and drives for decisions for strategic topics from a compliance and product quality perspective”
What You'll Achieve.
accelerate the development process; deliver safe and compliant solutions; enable risk-based decisions
Industry & Context.
Pragmatic decision making and ability to move forward without a perfect solution; effective resolution of issues (e. g. CAPA, NC)
What They're Looking For.
Must Have
Bachelor's degree in science, engineering, business administration or a related field, 8+ years of experience in the diagnostics industry or a related field in business related functions, scientific and technical background with sound product knowledge, business and financial acumen with an enterprise mindset, Knowledge of Regulations pertaining to the environment (i. e. ISO 13485, ISO 14971, GDP, GMP, others), Excellent communication, presentation, and negotiation skills, agile knowledge and capabilities demonstrating new ways of working, Pragmatic decision making and ability to move forward without a perfect solution, Demonstrated thorough E2E understanding for lifecycle management, leadership capabilities, with experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change
Nice to Have
MBA or advanced degree is considered an advantage, ideally with assay/reagents/system/hardware/software development experience for IVD Products
What You'll Do.
acts as a single point of contact within project teams (New product development / Product Change) for a portfolio of products assigned to them, leads and drives for decisions for strategic topics from a compliance and product quality perspective, partners with internal and external stakeholders across the value chain to accelerate the development process and incorporate learnings, Ensure consistent interpretation & implementation of global requirements across Customer Areas (CAs), Incorporate lessons learned from all areas of quality across Customer Areas (CA) into project support and ensure PostMarket Quality feedback is built into the requirements, Ensure development project plans contain the right deliverables according to the Design & Development module to deliver safe and compliant solutions, Support internal and external audits, Lead and facilitate constructive discussions e.
at project team meetings, Drive awareness and adoption of the Risk Enabler inside and outside of Global Quality & Regulatory decision prepare and enable risk-based decisions, Partner to ensure effective resolution of issues (e.
CAPA, NC), Ensure effective feedback loops and information flow for milestone review.
How You'll Work.
Team & Collaboration
partners with internal and external stakeholders across the value chain; Stakeholders include, but are not limited to Development Leads, Project Leaders, Regulatory Affairs, Operations, Global Customer Support, and Post-Market Quality; leading cross-functional teams (Squad Lead, Matrix Lead)
Communication Scope
Excellent communication, presentation, and negotiation skills
Process & Methodology
project teams (New product development / Product Change), development project plans, milestone review
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