Senior Quality Manager - Remote (Poland/Spain)

TFS HealthScience; Barcelona; Remote; EUR 70,000 - 100,000; Full time

Job summary

TFS HealthScience is seeking a Senior Quality Manager to oversee functional and project-level quality within a global CRO, with a home-based role in Poland or Spain. You will drive GCP/GxP compliance and support quality frameworks across client projects.

Lead CAPAs and risk management, perform audits, and guide internal teams while collaborating with clients to ensure robust quality management throughout clinical development.

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.

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.

Skills

Quality management

GxP auditing

GCP/GxP knowledge

QMS

Independent working

Education

Bachelor’s degree in Life Sciences

Job description

TFS HealthScience is seeking a Senior Quality Manager to oversee functional and project-level quality within a global CRO, with a home-based role in Poland or Spain. You will drive GCP/GxP compliance and support quality frameworks across client projects.

Lead CAPAs and risk management, perform audits, and guide internal teams while collaborating with clients to ensure robust quality management throughout clinical development.