Strategic Quality Partner

Roche•Carlsbad, NM

3d•$103,800 - $221,780•Onsite

About The Position

The Strategic Quality Partner acts as a single point of contact within project teams (New product development / Product Change) for a portfolio of products assigned to them. The SQP leads and drives for decisions for strategic topics from a compliance and product quality perspective. The SQP partners with internal and external stakeholders across the value chain to accelerate the development process and incorporate learnings. Stakeholders include, but are not limited to Development Leads, Project Leaders, Regulatory Affairs, Operations, Global Customer Support, and Post-Market Quality.

Requirements

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
Strong scientific and technical background with sound product knowledge, ideally with assay/reagents/system/hardware/software development experience for IVD Products.
Strong 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.
Strong 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
Strong leadership capabilities, with experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change.

Nice To Haves

MBA or advanced degree is considered an advantage.

Responsibilities

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.g. at project team meetings
Drive awareness and adoption of the Risk Enabler inside and outside of Global Quality & Regulatory decision making; prepare and enable risk-based decisions
Partner to ensure effective resolution of issues (e.g. CAPA, NC)
Ensure effective feedback loops and information flow for milestone review.