Quality Manager

TFS HealthScience - Contract Research Organization

Quality Manager at TFS HealthScience supporting clinical research and quality assurance activities. Responsible for QMS documentation, audits, and compliance in a global CRO environment.

Posted 5/16/2026full-timeLisboa • 🇵🇹 PortugalJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

Facilitates the generation and revision of all Quality Management System (QMS) Documents
Supports the risk assessment, Root Cause Analysis and Corrective Action Preventive Action (CAPA) Plan generation for all Quality Events
Drives the completion of relevant quality sections of Request for Proposal (RFP)/ Request for Information(RFIs)/quality assessments
Assists with the Computer System Validation (CSV) of all systems across the company
Prepare, conduct and follow up internal and vendor audits and the management of the resultant CAPA
Assists with hosting external audits
Provides input into the quality section of RFI / RFP and quality assessments
Maintains a library of questions and robust agreed answers
Prepares, conducts and follows up on internal GxP audits
Prepares, conducts and follows up on vendor audits
Supports and guides operational staff in preparing for customer audits
Assists with supporting and guiding operational staff in preparing for inspections including analyze risks and develop inspection readiness strategy

Requirements

What you’ll need

University/college degree or equivalent industry experience
Awareness of the clinical trials area / pharma industry, including knowledge of GxP regulations
Two years’ experience in clinical research and in the CSV field
Excellent interpersonal skills
Highly-analytical professional with strong attention to detail
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
Advance user of MS Office applications

Benefits

Comp & perks

Opportunities for personal and professional growth in a rewarding environment
Join a team that values collaboration, quality, and making a difference in the lives of patients
Core values of Trust, Quality, Passion, Flexibility, and Sustainability

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management System (QMS)Root Cause AnalysisCorrective Action Preventive Action (CAPA)Computer System Validation (CSV)GxP auditsRisk assessmentQuality assessmentsRequest for Proposal (RFP)Request for Information (RFI)Clinical research

Soft Skills

Interpersonal skillsAnalytical skillsAttention to detailProactive problem-solvingPlanningOrganizationMultitaskingPrioritizationCommunication skillsInspection readiness