Senior Manager, Quality Assurance – GCP Auditor

TFS HealthScience

contract

Posted on: 9/24/2025

Origin: • 🇵🇱 Poland

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Senior

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About the role

Prepare, conduct and follow up on all types of internal and external GxP/GCP audits
Provide leadership and support in clinical audit activities for internal and external parties (service providers, clinical sites)
Work with Business Leads to ensure resolution of audit findings/non-compliant issues and approve CAPA plans
Conduct peer review of audit reports and support operational staff preparing for customer audits
Host client and regulatory inspections and manage inspection readiness
Prepare investigational sites and guide staff in developing inspection readiness strategies
Act as subject matter expert for inspectors and train backroom support teams
Manage teams during inspections and host regulatory inspections for clients as required
Facilitate generation and revision of Controlled Documents (Policies, SOPs)
Support and guide completion of risk assessments and root cause analyses for Quality Issues
Assist in preparing robust CAPA plans and track them through to completion
Drive continuous improvement and development of routines to increase quality and compliance
Assist with business development of external quality and compliance services and attend client meetings
Provide quality advice and support to internal and external clients
Lead clinical non-compliance investigations and CAPA implementation; identify systemic gaps and escalate critical issues as appropriate

University/college degree in a scientific area (for Italy: Life Science degree required)
Awareness of the clinical trial area in CRO and/pharma industry
Knowledge of GCP/GxP regulations and standards (e.g., ICH E6 GCP)
Deep understanding of GCP/GxP regulations to interpret audit findings
At least five (5) years’ experience in clinical trials, including quality assurance and quality operations
CSV knowledge and experience are a plus
Adheres to ethical and good clinical practices
Ability to work as part of a team and independently in a remote workforce environment
Excellent interpersonal and communication skills
Ability to work on multiple projects with competitive timelines
Highly analytical with strong attention to detail
Pro-active, anticipates issues and develops 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)
For candidates based in Italy: compliance with the Italian MoH Decree dated 15th November 2011 (G.U. n°11 dated 14th January 2012)