Overview
Associate Director/Senior Manager, Quality Assurance (GCP Auditor) – hybrid in Warsaw, Poland or home based in Sweden, Italy or Portugal. The role is part of the Quality and Compliance team and focuses on quality oversight of GCP activities related to clinical trials, ensuring processes comply with regulatory requirements, ICH guidelines, SOPs, country-specific requirements, and current industry standards.
As part of our Quality and Compliance team, you will collaborate with passionate professionals to help customers achieve their goals.
Key Responsibilities
* Prepare, conduct and follow up on all types of internal and external GxP audits.
* Provide leadership in clinical audit activities for internal and external parties to ensure alignment with TFS standards, regulatory requirements, and quality expectations.
* Collaborate with Business Leads to resolve audit findings/non-compliant issues, approve CAPA plans, and ensure timely remediation.
* Conduct peer review of audit reports.
* Support and guide operational staff in preparing for customer audits and host client audits.
Inspection
* Prepare investigational sites for regulatory inspections as required.
* Guide operational staff in inspection readiness; analyze risks and develop readiness strategies.
* Act as subject matter expert for inspectors; train and prepare backroom support teams.
* Manage teams during inspections and host/regulatory inspections for clients as required.
Quality Management System
* Facilitate creation and updating of Controlled Documents; ensure alignment with regulatory requirements and standards.
* Support risk assessments and root cause analyses for Quality Issues; ensure documentation is suitable for clients.
* Assist in preparing robust CAPA Plans, track and manage them to completion.
* Drive continuous improvement and develop routines to increase quality and compliance.
Client Interactions
* Assist with business development of external quality and compliance services.
* Lead or participate in client visits/meetings when required.
Support
* Provide quality advice and support to internal and external clients.
* Lead investigations of clinical non-compliance events and implement CAPA, including trend monitoring and effectiveness checks.
* Identify systemic gaps and coordinate with stakeholders to ensure timely remediation; escalate critical non-compliance or urgency issues as needed to Head of Quality and Compliance.
Qualifications
* University/college degree in a scientific area (Italy: Life Science degree required).
* Awareness of the clinical trial CRO/pharma industry and knowledge of GCP/GxP regulations.
* Deep understanding of GCP/GxP regulations and standards to interpret audit findings.
* At least five (5) years’ experience in clinical trials, including quality assurance and quality operations; CSV knowledge a plus.
* Ability to work ethically and collaboratively in a remote environment; strong communication skills.
* Excellent interpersonal and written/oral communication skills; ability to manage multiple projects with tight timelines.
* Highly analytical, detail-oriented, proactive problem solver with good planning and organizational skills.
* Fluent in English (written and verbal).
* Advanced user of MS Office (Outlook, Word, Excel, PowerPoint).
What We Offer: We provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. You’ll join a team that values collaboration, innovation, and making a difference in the lives of patients.
About Us
Our journey began over 29 years ago in Sweden, Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams for a healthier future. We have over 800 professionals in more than 40 countries, delivering clinical research services across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values are Trust, Quality, Passion, Flexibility, and Sustainability, guiding decision-making and fostering a culture of collaboration and excellence.
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