17 ago
|
TFS HealthScience
|
Madrid
17 ago
TFS HealthScience
Madrid
TFS HealthScience is a leading integral mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as a
Principal Quality Manager (home-based in Poland or Spain)
About This Role
As part of our
Quality
team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The
Principal Quality Manager
acts as a subject matter expert and escalation lead for complex quality issues, inspection readiness, and quality risk management, and ensures consistent, compliant and inspection-ready execution of quality activities across projects, vendors, and systems, while coaching and mentoring Quality Managers and supporting continuous improvement of the Quality Management System
Key Responsibilities
- Maintains quality oversight for multiple projects, vendors, and/or systems, ensuring consistent and compliant execution.
- Acts as escalation point for complex, high-risk or systemic quality issues, inspection risks, and compliance concerns within assigned scope.
- Leads complex investigations, including suspected serious breaches, fraud and misconduct and systemic quality issues; ensures robust CAPA development, effectiveness checks, and trend analysis.
- Acts as lead auditor for routine audits and leads complex audits and inspections; defines inspection response strategy, coordinates execution, and supports senior management during high‑risk or regulatory‑critical inspections. Leads inspection readiness activities.
- Acts as subject matter expert for one or more QMS elements (e.g. CAPA, Audit Program, Vendor Quality Management, Inspection Readiness, Training Compliance, CSV Quality Oversight) and supports continuous improvement initiatives within those areas
- Develops, reviews, and maintains controlled documents withi
📌 Principal Quality Manager (Madrid)
🏢 TFS HealthScience
📍 Madrid