EU remote
Senior Quality Manager
About this role
TFS HealthScience is a leading global 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 Senior 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 Senior Quality Manager is responsible for for functional and project-level quality oversight within the assigned scope, and for dedicated assigned quality management area. Key Responsibilities: Provides functional and project-level quality oversight across assigned scope, ensuring compliance with GCP and other applicable GxP regulations. Support and participate in eQMS lifecycle activities, with a particular focus on validation oversight and compliance, as required.
Oversees and performs vendor quality management activities, including qualification, risk assessment, and RFIs; reviews and approves outputs generated by Quality Managers Supports business units and clients on projects, including development and maintenance of project-specific quality frameworks and procedures. Generates, reviews and approves controlled documents; ensures consistency, regulatory compliance, and alignment with the QMS.
Manages quality issues and CAPAs, including oversight of investigations, escalation of significant risks or delays, and decision-making on critical issues and suspected serious breaches. Participates in quality risk management activities, including risk identification, assessment, and review · Interpedently conducts GCP/GxP audits of vendors, systems and clinical trials. Qualifications: Bachelor’s degree in Life Sciences (or equivalent experience) 5+ years in quality management/QA; 5+ years in GxP auditing - nice to have Strong expertise in GCP/GxP, QMS, and system validation Proven ability to work independently and lead complex quality activities TFS is committed to equal opportunities.