Senior Quality Manager (Home-based Poland or Spain)

About the role

TFS HealthScience is a global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies through their entire clinical development journey. It is looking for a Senior Quality Manager, home-based in Poland or Spain, to join its Quality team and work alongside colleagues to help customers achieve their goals. The role covers functional and project-level quality oversight within an assigned scope and a dedicated quality management area.

Key responsibilities

• Provide functional and project-level quality oversight, ensuring compliance with GCP and other applicable GxP regulations
• Support and take part in eQMS lifecycle activities, especially validation oversight and compliance
• Oversee vendor quality management, including qualification, risk assessment and RFIs, and review and approve outputs from Quality Managers
• Support business units and clients on projects, developing and maintaining project-specific quality frameworks and procedures
• Generate, review and approve controlled documents, keeping them consistent, compliant and aligned with the QMS
• Manage quality issues and CAPAs, oversee investigations, escalate significant risks or delays and decide on critical issues and suspected serious breaches
• Take part in quality risk management, including risk identification, assessment and review
• Conduct GCP/GxP audits of vendors, systems and clinical trials

Required profile

• Bachelor's degree in Life Sciences (or equivalent experience)
• 5+ years in quality management/QA
• 5+ years in GxP auditing (nice to have)
• Proven ability to work independently and lead complex quality activities

Required skills

• Strong expertise in GCP/GxP, QMS and system validation
• GxP auditing experience (nice to have)

What we offer

• A competitive compensation package
• Comprehensive benefits
• Opportunities for personal and professional growth