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 Freelance Associate Director, Quality Assurance (GCP Auditor) - hybrid in Warsaw, Poland / Lund, Sweden or home based in UK, 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 Freelance Associate Director, Quality Assurance (GCP Auditor) works very closely with the Senior Director of Quality Management and deputises for them in all areas. They will have line management responsibilities.

The Freelance Associate Director, Quality Assurance (GCP Auditor) is capable of independently conducting work related to the development, improvement and daily management of the TFS QMS as well as managing the Quality Management System and the associated documentation. They manage the Annual Audit Plan and tracking of all audits. They will also manage the recording of issues (including complaints and serious breach), managing CAPA and Computerised Systems Validation.

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

Key Responsibilities

AUDIT:

• Ensure the Annual Audit Plan is prepared, followed and maintain 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 and effectiveness verification and Final QA Approval of CAPA.
• Oversight and management of Complaints, Potential Serious Breach and Potential Fraud and Scientific Misconduct investigations are completed thoroughly and on time, as appropriate.
• Actively contributes to continuous improvement of the organisation Responsible for contributing to the development and improvement of TFS Quality Management System, as appropriate Responsible for ensuring all teams across the organisation receive appropriate facilitation to prepare new and update all types of QMS Documents.
• Responsible for developing new and updating 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
• Informing Vendor Management when issues/complaints are raised and working 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 clients 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 all are completed, accurately and fully.
• Act as trainer both 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 and activities 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 on 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 as an advantage

For candidates based in Italy - you will need to be compliant with the Italian MoH Decree dated on 15th November 2011(G.U. n°11 dated on 14th January 2012). We 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.