Freelance Senior Manager, Quality Assurance (GCP Auditor) (0.8-1.0 FTE)

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

Join Our Team as a Senior Manager, Quality Assurance (GCP Auditor) - hybrid in Warsaw, Poland / Lund, Sweden or home based in Italy or Portugal.

About this role

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

The Senior Manager, Quality Assurance (GCP Auditor) is responsible for ­­­­­­­­­­­­­­­­­the quality oversight of the GCP activities related to clinical trials. The Senior Manager, Quality Assurance performs day-to-day clinical quality operations and compliance activities to support the success of the clinical trial projects. The primary responsibility is to ensure that clinical processes are conducted in accordance with the applicable regulatory requirements, ICH Guidelines (e.g. ICH E6 GCP), Standard Operating Procedures and country-specific requirements, along with current industry standards and practices.

The S enior Manager, Quality Assurance (GCP Auditor) facilitates the generation and revision of the Controlled Documents (e.g., Policies, SOPs); supports the Risk Assessment, Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) Plan generation for the Quality Issues (QIs); drives the completion of the relevant quality sections of Request for Proposal (RFP) / Request for Information (RFIs) / quality assessments; assists with the GxP Computer System Validation (CSV); prepares, conducts and follow up with on all types of the GCP / GxP internal and external audits, including hosting external audits and conducting activities to ensure inspection readiness.

This person has experience in clinical research and quality assurance and is able to provide support and advice throughout this area.

Key Responsibilities

AUDIT :

• Prepares, conducts and follow up on all types of internal and external GxP audits
• Supports and provides leadership in clinical audit activities for both internal and external parties (e.g., service providers, clinical sites) to ensure alignment with TFS standards, regulatory requirements, and quality expectations.
• Works closely with Business Leads to ensure / coordinate appropriate and complete resolution of audit findings / non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as required.
• Conducts peer review of audit reports
• Supports and guides operational staff in preparing for customer audits
• Hosts client audits

INSPECTION :

QUALITY MANAGEMENT SYSTEM :

CLIENT INTERACTIONS :

SUPPORT :

Qualifications

For candidates based in Italy - y ou will need to be compliant with the Italian MoH Decree dated on 15th November 2011(G.U. n°11 dated on 14th January 2012). W e also welcome applications from candidates belonging to protected categories under art. 1 L. 68 / 99.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 29 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.