Senior Quality Manager

Senior Quality Manager

TFS HealthScience

Warsaw, Madrid or Barcelona

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, including validation oversight activities, 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.

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.