Remote Senior Quality Manager - GxP/GCP Compliance Leader

TFS HealthScience; Województwo mazowieckie; Remote; PLN 393,000 - 568,000; Full time

Benefits offered by this job

Competitive compensation package

Comprehensive benefits

Personal and professional growth

Job summary

TFS HealthScience is recruiting a Senior Quality Manager for a home-based role in Poland or Spain. You will join our Quality team to ensure compliance with GCP/GxP and lead quality activities across projects and vendors.

You will support eQMS lifecycle activities, oversee CAPAs, and drive risk management in a globally focused CRO environment, delivering high-quality outcomes for patients and sponsors.

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

QMS

System validation

Independent work

Quality leadership

Education

Bachelor’s degree in Life Sciences

Job description

TFS HealthScience is recruiting a Senior Quality Manager for a home-based role in Poland or Spain. You will join our Quality team to ensure compliance with GCP/GxP and lead quality activities across projects and vendors.

You will support eQMS lifecycle activities, oversee CAPAs, and drive risk management in a globally focused CRO environment, delivering high-quality outcomes for patients and sponsors.