Quality Business Partner, Pre-clinical Research
Core
Strategic quality advocate for R&D pre-clinical research, embedding Quality by Design and risk minimization into research processes.
Role type
Senior Quality Business Partner (Pre-clinical R&D)
Builds
Integrated quality strategies and risk management frameworks for non-clinical research
Domain
Biopharmaceuticals / Pre-clinical Research / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality by Design, Risk Analysis, GLP/GCP knowledge, Animal Welfare regulations, Continuous Improvement, Stakeholder Management, Root Cause Analysis, CAPA development, KPI/KQI definition, Due diligence support
Preferred skills
Emerging technology quality strategies (organoids, AI/ML), Strategic quality planning, Analytical mindset, Cross-functional collaboration
Technologies
None explicitly listed
Responsibilities
Define quality activities for R&D research, Collaborate with Risk and Issue Management teams, Share best practices to drive quality, Evaluate procedures for integrated QMS, Support due diligence and M&A activities, Communicate quality issues and risks, Support investigations of critical issues, Define metrics needs with Data Analytics
Seniority
Senior, strategic advisor & consultant
