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Senior Manager, Quality Assurance (GCP Auditor), Lisbon
Client: TFS HealthScience
Location: Lisbon, Portugal
Job Category: Other
EU work permit required: Yes
Job Reference: 912b8875d20b
Job Views: 5
Posted: 19.08.2025
Expiry Date: 03.10.2025
Job Description:
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout clinical development. Our expertise includes full service capabilities, resourcing, and Functional Service (FSP) solutions.
Join Our Team as a Senior Manager, Quality Assurance (GCP Auditor) - hybrid in Warsaw, Poland or home-based in Sweden, Italy, or Portugal.
About this role
As part of our Quality and Compliance team, you will work alongside passionate professionals to ensure our customers achieve their goals. The Senior Manager, Quality Assurance (GCP Auditor) is responsible for quality oversight of GCP activities related to clinical trials, performing day-to-day clinical quality operations and compliance activities to support clinical trial success.
This role involves ensuring clinical processes comply with regulatory requirements, ICH Guidelines (e.g., ICH E6 GCP), SOPs, country-specific requirements, and industry standards. The Senior Manager facilitates document generation and revision, supports risk assessments, root cause analysis, CAPA plans, and prepares for audits, including hosting external audits and ensuring inspection readiness.
The ideal candidate has experience in clinical research and quality assurance, providing support and advice in these areas.
Key Responsibilities
* Prepares, conducts, and follows up on GxP audits
* Supports clinical audit activities for internal and external parties
* Coordinates resolution of audit findings and non-compliance issues
* Prepares sites for regulatory inspections and manages inspection processes
* Supports the generation and updating of Controlled Documents
* Assists with risk assessments, root cause analysis, and CAPA plans
* Supports business development of quality services and client interactions
* Provides quality advice and leads investigations of non-compliance events
Qualifications
* Degree in a scientific field (Life Science degree preferred for Italy)
* Knowledge of GCP/GxP regulations and clinical trial industry
* At least 5 years in clinical trials with QA experience; CSV knowledge is a plus
* Excellent communication skills, fluent in English
* Proficient in MS Office
We welcome applications from candidates in Italy belonging to protected categories under art. 1 L. 68/99.
What We Offer
Competitive compensation, benefits, and growth opportunities in a collaborative environment.
About Us
Founded over 29 years ago in Sweden, TFS HealthScience is a global CRO with over 800 professionals across 40 countries, specializing in various therapeutic areas and committed to our core values of Trust, Quality, Passion, Flexibility, and Sustainability.
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