Freelancer Senior Quality Manager, Quality Assurance

buscojobs España; León; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading global Contract Research Organization is seeking a Freelance Senior Manager for Quality Assurance. This role involves ensuring compliance with regulatory requirements and overseeing quality operations for clinical trials. Candidates should have a scientific degree and at least 5 years of experience in QA and clinical trials, with strong communication and analytical skills.

Servicios

Competitive compensation

Comprehensive benefits

Growth opportunities

Formación

• Minimum 5 years’ experience in clinical trials, QA, and operations.
• Strong understanding of ethical practices and ability to work independently.
• Fluent in English, both written and verbal.

Responsabilidades

• Ensure compliance with GCP activities related to clinical trials.
• Facilitate generation and updating of Controlled Documents.
• Conduct internal and external GxP audits.

Conocimientos

Communication

Analytical skills

Organizational skills

Educación

Degree in a scientific field

Herramientas

MS Office applications

Descripción del empleo

Freelancer Senior Quality Manager, Quality Assurance

EUR 60.000 - 80.000

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing, and Functional Service Provider (FSP) solutions.

Join Our Team as a Freelance Senior Manager, Quality Assurance - UK, Poland, Spain, Portugal or Italy About this role

As part of our Quality and Compliance Department , you will work alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Senior Manager, Quality Assurance is responsible for the quality oversight of GCP activities related to clinical trials. This role involves performing day-to-day clinical quality operations and compliance activities to support successful clinical trial projects. The primary responsibility is to ensure that clinical processes comply with applicable regulatory requirements, ICH Guidelines (e.g., ICH E6 GCP), Standard Operating Procedures, country-specific requirements, and current industry standards.

The Senior Manager facilitates the creation and revision of Controlled Documents (e.g., Policies, SOPs); supports Risk Assessments, Root Cause Analysis (RCA), and Corrective and Preventive Action (CAPA) plans for Quality Issues; contributes to quality assessments in RFPs / RFIs; assists with GxP Computer System Validation (CSV); and prepares, conducts, and follows up on GCP / GxP audits, including hosting external audits and ensuring inspection readiness.

Key Responsibilities : QUALITY MANAGEMENT SYSTEM :

• Facilitate generation and updating of Controlled Documents, ensuring alignment with regulatory standards.
• Support staff in conducting risk assessments and root cause analyses for Quality Issues, ensuring timely completion and proper documentation.
• Assist in preparing robust CAPA Plans, tracking and managing them to completion.
• Drive continuous improvement initiatives to enhance quality and compliance.

INSPECTION :

• Prepare investigational sites for regulatory inspections.
• Guide staff in inspection readiness strategies and risk analysis.
• Act as SME during inspections and ensure team preparedness.
• Manage and host regulatory inspections.

AUDIT :

• Conduct and follow up on internal and external GxP audits.
• Lead clinical audit activities and ensure resolution of audit findings.
• Review audit reports and prepare clients for audits.

COMPUTER SYSTEMS VALIDATION :

• Support CSV activities across the company.

RFIs / RFPs :

• Contribute to quality sections of RFI / RFP documents and maintain question libraries.

CLIENT INTERACTIONS :

• Support business development in external quality and compliance services.
• Lead or attend client visits and meetings.

SUPPORT :

• Provide quality advice to internal and external clients.
• Lead investigations of non-compliance events and implement CAPAs.
• Identify systemic gaps and coordinate remediation efforts.

Qualifications :

• Degree in a scientific field.
• Knowledge of GCP / GxP regulations and clinical trial industry.
• Minimum 5 years’ experience in clinical trials, QA, and operations; CSV experience is a plus.
• Strong understanding of ethical practices and ability to work independently and remotely.
• Excellent communication, analytical, and organizational skills.
• Fluent in English, both written and verbal.
• Proficiency in MS Office applications.

What We Offer

Competitive compensation, comprehensive benefits, and growth opportunities in a collaborative environment dedicated to making a difference in patients’ lives.

About Us

Founded over 27 years ago in Lund, Sweden, TFS is a full-service global CRO with over 800 professionals in more than 40 countries, specializing in therapeutic areas like Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—guide our decision-making and culture. Together we make a difference.

J-18808-Ljbffr