Associate Director​/Senior Manager, Quality Assurance; GCP Auditor

Position: Associate Director/Senior Manager, Quality Assurance (GCP Auditor)
Overview  TFS Health Science is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as an Associate Director/Senior Manager, Quality Assurance (GCP Auditor) - hybrid in Warsaw, Poland or home based in Sweden, Italy or Portugal.
Responsibilities   Prepares, conducts and follows up on all types of internal and external GxP audits
Supports and provides leadership in clinical audit activities for both internal and external parties to ensure alignment with TFS standards, regulatory requirements, and quality expectations
Works closely with Business Leads to coordinate appropriate and complete resolution of audit findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventive action (CAPA) plans as required
Conducts peer review of audit reports
Supports and guides operational staff in preparing for customer audits
Hosts client audits
Prepares investigational sites for regulatory inspections, as required
Guides operational staff in preparing for inspections including analysing risks and developing inspection readiness strategy
Acts as a subject matter expert for inspectors and ensuring the Business Unit team members are fully prepared for interactions; provides training/preparation to the backroom support team
Manages team during inspections
Hosts and manages regulatory inspections for clients, as required
Quality Management System   Facilitates teams from across the company in generating / updating Controlled Documents; driving the process to ensure Controlled Documents are aligned with the regulatory requirements and the applicable standards
Supports staff from across the company to complete accurate and detailed risk assessments and root cause analysis for all Quality Issues, ensure they are completed on time and documentation is always suitable to share with clients as appropriate
Assists staff to prepare appropriate and robust CAPA Plans (for Quality Issues), track and manage these through to completion ensuring the CAPAs are completed on the due date
Drive and actively contribute to continuous improvement of the organisation and development of routines that aim to increase quality and improve compliance
Client Interactions   Assists with business development of external quality and compliance services
Leads / attends client visits / client meetings when required
Support   Provide quality advice and support to internal clients and external clients
Leads clinical non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checks
Identifies potential systemic gaps and coordinates with the appropriate stakeholders to ensure timely remediation. As appropriate, escalates issues of critical non-compliance and/or lack of urgency in remediation to the Head of Quality and Compliance
Qualifications   University/college degree in a scientific area (Italy: Life Science degree level education is required)
Awareness of the clinical trial area in the CRO and/pharma industry, including knowledge of GCP/GxP regulations
Deep understanding of GCP/GxP regulations and standards to facilitate the interpretation and impact of findings of internal and external audits
At least five (5) years’ experience in clinical trials, including quality assurance and quality operation experience. CSV knowledge and experience are a plus
Adheres to ethical and good clinical practices and the ability to work as part of a team, as well as work independently in a remote workforce environment
Excellent interpersonal and communication skills and the ability to work on multiple projects with competitive timelines
Highly analytical professional with strong attention to detail and respect for the need for accuracy of information
Pro-active, recognizing and anticipating issues, addressing problems and developing solutions
Good planning, organisation and problem-solving abilities
Demonstrated ability to multitask, prioritize, and complete objectives
Excellent oral and written communication skills
Fluent in English, both written and verbal
Advanced user of MS Office applications (Outlook, Word, Excel, PowerPoint)

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.

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