Senior Quality Manager - Remote (Poland/Spain)

TFS HealthScience; Warszawa; Remote; PLN 306,000 - 481,000; Full time

Job summary

TFS HealthScience is actively seeking a Senior Quality Manager to lead quality oversight across projects, ensuring GCP/GxP compliance and robust QMS implementation. This home-based role can be based in Poland or Spain, reflecting our global, client-focused CRO model.

In this senior position, you will drive eQMS lifecycle activities, oversee vendor QA processes, and manage CAPAs and investigations. You will collaborate with cross-functional teams to sustain risk-based quality management and

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

GCP/GxP knowledge

QMS

System validation

Quality management

CAPA management

Auditing (GxP)

Education

Bachelor's degree in Life Sciences

Tools

eQMS software

Document control systems

Job description

TFS HealthScience is actively seeking a Senior Quality Manager to lead quality oversight across projects, ensuring GCP/GxP compliance and robust QMS implementation. This home-based role can be based in Poland or Spain, reflecting our global, client-focused CRO model.

In this senior position, you will drive eQMS lifecycle activities, oversee vendor QA processes, and manage CAPAs and investigations. You will collaborate with cross-functional teams to sustain risk-based quality management and