Overview

Freelance Associate Director, Quality Assurance (GCP Auditor) (0.8-1.0 FTE) – hybrid in Warsaw, Poland / Lund, Sweden or home based in UK, Italy or Portugal.

Responsibilities

• Ensure the Annual Audit Plan is prepared, followed and maintained along with the Audit Progress Report.
• Responsible for tracking all audit types and ensuring all are completed.
• Prepare, conduct and follow up on all types of internal and external GxP audits.
• Support and guide operational staff in preparing for customer audits.
• Responsible for hosting / facilitating customer audits of the company and/or projects.
• Review and approve audit reports for other quality management personnel and provide advice and direction as required.
• Act as Quality Lead Auditor when applicable.

Inspection

• Assist in preparing investigational sites for regulatory inspections, as required.
• Support and guide operational staff in preparing for inspections including analyse risks and develop inspection readiness strategy.
• Provide training/preparation to the backroom support team; manage team during inspections.
• Host regulatory inspections for clients, as required.
• Responsible for hosting and managing regulatory inspections of TFS, as required.

Quality Management System

• Oversight, management and support of Quality Issues including review and approval of Risk Reviews.
• QI and Audit/Inspection CAPA including review and approval of CAPA plans; approval of closure of action items including effectiveness verification and Final QA Approval of CAPA.
• Oversight and management of Complaints, Potential Serious Breach and Potential Fraud and Scientific Misconduct investigations, completed thoroughly and on time, as appropriate.
• Contributes to continuous improvement of the organisation; responsible for developing and updating TFS Quality Management System documents and ensuring teams receive appropriate facilitation.
• Develops new and updates quality management QMS Documents as required.

Support

• Provide quality management advice and support to all internal staff and departments.
• Ensure continuous audit readiness, regulatory inspection support and monitoring.

Vendor Management

• Responsible for ensuring all GxP vendors are assessed, whether for clients or TFS.
• Inform Vendor Management when issues/complaints are raised and work with Vendor Management to resolve these.

Metrics

• Responsible for audit metrics and assisting with Quality Management metrics as required.

Client Interactions

• Responsible for hosting Quality Committees with TFS business units.
• Provide quality management advice and support to external clients.
• Perform client visits / attend client meetings when required.

Business Development

• Assist in providing input into proposals and costings, which include quality management and securing external quality management services.
• Accompany business development colleagues on customer visits and participate in presentations when required.

Miscellaneous

• Review MSAs/Quality Agreements and other agreements to ensure TFS can comply with the quality sections and all risks are minimised.
• Oversight and management of all RFIs and RFPs to ensure they are completed accurately and fully.
• Act as trainer for Quality Management and all TFS staff, as and when needed.
• Prepare and distribute the Regulatory Intelligence Newsletter quarterly.
• Maintain required knowledge of applicable regulations and company GxP standards and procedures.
• Participate in internal meetings as required and liaise with other departments as necessary; other tasks delegated by Senior Director Quality Management within scope of experience.

Qualifications

• University/college degree or equivalent industry experience.
• Awareness of global and local industry trends, government policies and regulations in the clinical trials and pharmacovigilance area.
• In-depth knowledge of GxP (including CSV) regulations and guidance.
• Previous auditing experience is required, with thorough knowledge of requirements for GxP compliance; knowledge of GxP regulated computerized system validation activities and principles.
• Previous audit management experience.
• Good computer skills (Microsoft Word and Excel).
• Ability to work independently and efficiently.
• Good planning, organisation and problem-solving abilities.
• Fluent in English, both written and verbal.
• Several years’ experience in clinical research (e.g., monitoring, data management, drug safety, training, etc.).
• Five to ten years’ experience of auditing in two to three GxP areas.
• International travel to audit sites, worldwide.
• Membership of a quality association (e.g. the Research Quality Association) is considered an advantage.

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.

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 guide decision-making at all levels of the organization. By aligning on these values, we cultivate a culture of mutual respect and collaboration. Together we make a difference.