Associate Director / Senior Manager, Quality Assurance (GCP Auditor)

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full service capabilities, resourcing, and Functional Service Provider (FSP) solutions.

Join our team as an Associate Director / Senior Manager, Quality Assurance (GCP Auditor) - hybrid in Warsaw, Poland, or home-based in Sweden, Italy, or Portugal.

About this role

As part of our Quality and Compliance team, you will work alongside passionate professionals to ensure our customers achieve their goals.

The Associate Director / Senior Manager, Quality Assurance (GCP Auditor) is responsible for overseeing GCP activities related to clinical trials. The role involves day-to-day clinical quality operations and ensuring compliance with regulatory requirements, ICH Guidelines (e.g., ICH E6 GCP), SOPs, and country-specific standards.

This role includes generating and revising controlled documents, supporting risk assessments, root cause analyses, CAPA plans, and preparing for audits and inspections. The ideal candidate has clinical research and quality assurance experience and can provide guidance throughout these processes.

Key Responsibilities

AUDIT :

• Conduct and follow up on internal and external GxP audits.
• Lead clinical audit activities, ensuring alignment with standards and requirements.
• Coordinate resolution of audit findings and non-compliance issues, including CAPA approval.
• Review audit reports peer-wise.
• Assist staff in preparing for customer audits and host external audits.

INSPECTION :

• Prepare investigational sites for regulatory inspections.
• Guide staff in inspection readiness, analyze risks, and develop strategies.
• Act as SME for inspectors and support team training.
• Manage and host regulatory inspections.

QUALITY MANAGEMENT SYSTEM :

• Facilitate creation and updating of controlled documents.
• Support risk assessments and root cause analyses for Quality Issues.
• Assist in CAPA plan development and tracking.
• Drive continuous improvement initiatives.

CLIENT INTERACTIONS :

• Support business development of quality services.
• Lead or attend client meetings and visits.

SUPPORT :

• Provide quality advice to clients.
• Lead investigations and CAPA implementations for non-compliance events.
• Identify systemic gaps and escalate critical issues.

Qualifications

• Degree in a scientific field (Life Science degree for Italy).
• Knowledge of GCP/GxP regulations and clinical trial processes.
• Minimum 5 years’ experience in clinical trials, QA, and operations; CSV experience is a plus.
• Strong communication, analytical, and organizational skills.
• Proactive problem-solver with excellent multitasking abilities.
• Fluent in English, both written and verbal.
• Proficient in MS Office.

For Italian candidates, we welcome applications from protected categories under art. 1 L. 68/99.

What We Offer

Competitive compensation, benefits, and growth opportunities within a collaborative environment.

About Us

Founded over 29 years ago in Sweden, TFS is a global CRO with over 800 professionals in more than 40 countries, specializing in therapeutic areas like Dermatology, Oncology, Neuroscience, and Ophthalmology. Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—guide our decision-making and culture. We are committed to making a difference in patients' lives.