Overview

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

Join our Quality and Compliance team to ensure our customers achieve their goals. The Freelance Associate Director, Quality Assurance (GCP Auditor) works closely with the Senior Director of Quality Management and may deputise for them in all areas. This role has line management responsibilities and involves development, improvement and daily management of the TFS QMS, managing the Annual Audit Plan and tracking audits, recording issues (including complaints and serious breach), managing CAPA and Computerised Systems Validation. They bring broad experience in clinical research and quality management to provide support and guidance in these areas.

Key Responsibilities

Audit

• Ensure the Annual Audit Plan is prepared, followed and maintained along with the Audit Progress Report.
• Track all audit types and ensure timely completion.
• Prepare, conduct and follow up on internal and external GxP audits.
• Support and guide operational staff in preparing for customer audits.
• Host/facilitate customer audits of the company and/or projects.
• Review and approve audit reports for other quality management personnel and provide guidance 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; analyse risks and develop inspection readiness strategies.
• Provide training/preparation to backroom support and manage the team during inspections.
• Host regulatory inspections for clients, as required.
• Host and manage regulatory inspections of TFS as required.

Quality Management System

• Oversee and support Quality Issues including review/approval of Risk Reviews.
• Oversee CAPA including review/approval of CAPA plans, closure items and effectiveness verification with final QA approval.
• Lead investigations into Complaints, Potential Serious Breach and Potential Fraud/Scientific Misconduct as appropriate.
• Contribute to continuous improvement of the organisation and development of the TFS QMS; facilitate QMS documents across teams.
• Develop/update QMS documents as required.

Support

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

Vendor Management

• Ensure GxP vendors are assessed for clients or TFS and inform Vendor Management of issues/complaints to resolve.

Metrics

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

Client Interactions

• Host Quality Committees with TFS business units; provide quality management advice to external clients.
• Perform client visits/attend client meetings when required.

Business Development

• Provide input into proposals and costings including quality management; participate in customer visits and presentations as needed.

Miscellaneous

• Review MSAs/Quality Agreements to ensure compliance with quality sections and minimise risks.
• Oversee RFIs and RFPs to ensure completeness and accuracy.
• Act as trainer for Quality Management and TFS staff as needed.
• Prepare and distribute the Regulatory Intelligence Newsletter quarterly.
• Maintain knowledge of applicable regulations and GxP procedures; participate in internal meetings and liaise with other departments.
• Other tasks delegated by the Senior Director Quality Management within scope of experience.

Qualifications

• University/college degree or equivalent industry experience.
• Awareness of global/local industry trends, policies and regulations in clinical trials and pharmacovigilance.
• In-depth knowledge of GxP (including CSV) regulations and guidance; previous auditing experience with thorough knowledge of GxP compliance; familiarity with GxP regulated computerized system validation.
• Good computer skills (Word and Excel) and ability to work independently.
• Strong planning, organisation and problem-solving abilities.
• Fluent in English, both written and verbal.
• Several years of experience in clinical research (e.g., monitoring, data management, drug safety, training).
• Five to ten years of auditing experience in two to three GxP areas; willingness to travel internationally to audit sites.
• Membership of a quality association (e.g., Research Quality Association) is an advantage.

Note: For candidates based in Italy, compliance with the Italian MoH Decree dated 15 November 2011 is required. We welcome applications from protected categories under art. 1 L. 68/99.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and opportunities for growth in a collaborative environment dedicated to making a difference in patients’ lives.

About Us

TFS HealthScience is a global mid-size CRO with 29 years of experience, delivering clinical research services in more than 40 countries and across key therapeutic areas. Our values are Trust, Quality, Passion, Flexibility, and Sustainability.

Together we make a difference.