Freelance Associate Director, Quality Assurance (GCP Auditor) (0.8-1.0 FTE) Porto

Overview

Join to apply for the Freelance Associate Director, Quality Assurance (GCP Auditor) (0. 8-1. 0 FTE) role at TFS Health
Science. Hybrid in Warsaw, Poland / Lund, Sweden or home based in UK, Italy or Portugal.

About this role: as part of the Quality and Compliance team you will work alongside passionate and innovative professionals 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 deputises for them in all areas, with 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, and manage recording of issues (including complaints and serious breach), CAPA and Computerised Systems Validation. This person has broad experience in clinical research and quality management and can provide support and advice throughout this area.

Key Responsibilities

AUDIT:

• 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 Gx
  P 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 actions 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 as appropriate.
• Contributes to continuous improvement of the organisation; supports development and improvement of the TFS Quality Management System and ensures teams receive appropriate facilitation to prepare/update QMS documents.
• Develops 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:

• Ensure all Gx
  P 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:

• Host 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, including 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 minimise risks.
• 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 needed.
• Prepare and distribute the Regulatory Intelligence Newsletter quarterly.
• Maintain required knowledge of applicable regulations and company Gx
  P standards and procedures.
• Participate in internal meetings and liaise with other departments as necessary; perform other tasks as delegated by the 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 Gx
  P (including CSV) regulations and guidance.
• Previous auditing experience required with thorough knowledge of Gx
  P compliance; knowledge of Gx
  P regulated computerized system validation activities and principles.
• Good computer skills (Microsoft Word and Excel).
• Ability to work independently and efficiently.
• Good planning, organisation and
  - 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 Gx
  P areas.
• International travel to audit sites, worldwide.
• Membership of a quality association (e. g. the Research Quality Association) is considered advantageous.

For candidates based in Italy, you will need to be compliant with the Italian Mo
H Decree dated 15 November 2011. 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.

About Us

Our journey began over 29 years ago in Lund, Sweden. As a
- service, global Contract Research Organization (CRO), we build
- 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 are Trust, Quality, Passion, Flexibility, and Sustainability.

Together we make a difference.

Seniority level: Not Applicable | Employment type: Contract | Job function: Quality Assurance | Industries: Pharmaceutical Manufacturing

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