Quality Management Associate - North America / Europe - Remote

Worldwide Clinical Trials; Madrid; A distancia; EUR 35.000 - 45.000; Jornada completa

Descripción de la vacante

A leading global CRO is seeking a Quality Management Associate to champion the adoption of the Quality Management System and provide oversight on quality issues. The ideal candidate will hold a relevant degree and have 2+ years of GCP experience. This full-time role is remote and offers opportunities for international travel. Join us to make a difference in research services.

Formación

• 2+ years of GCP experience required.
• Knowledge of ICH Guidelines and FDA regulations is necessary.
• Understanding of the Drug Development Process is essential.

Responsabilidades

• Champion the adoption of the Quality Management System (QMS).
• Provide consultancy for project-specific Quality Issues and CAPA plans.
• Support risk assessment activities within Risk Based Quality Management.

Conocimientos

Professional communication skills

Customer-focused approach

Critical thinking skills

Flexibility

Educación

Degree in nursing, biological, physical, health, pharmacy, or related science

Herramientas

Microsoft Office

Descripción del empleo

Quality Management Associate - North America / Europe - Remote

Join to apply for the Quality Management Associate role at Worldwide Clinical Trials.

Who We Are

We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, a global team of over 3,500+ experts, bright thinkers, dreamers, and doers, changing the way the world experiences CROs – in the best way.

Our mission is to work with passion and purpose every day to improve lives. We value diversity and inclusion, creating a workplace where everyone can thrive and do their best work.

What The Quality Assurance Department Does

The QA department sets high standards for quality, exceeding sponsor, participant, and regulatory requirements. We foster an environment where staff are trained, energized, and empowered to deliver high-quality products.

What You Will Do

1. Champion the adoption of the Quality Management System (QMS).
2. Provide consultancy and oversight for project-specific Quality Issues (QIs) and CAPA plans.
3. Maintain electronic filing and management of QI and CAPA documentation.
4. Act as GCP / GLP / GcLP Subject Matter Expert (SME), providing consultancy to project teams.
5. Review project-specific Quality Management Documents deviations.
6. Perform study data review and trending activities.
7. Support risk assessment activities within Risk Based Quality Management.
8. Assist with oversight and follow-up of CAPA plan execution.
9. Collaborate with the Quality Lead (Therapeutic Area, Bioanalytical, or Phase 1 Clinic).
10. Support sponsor audits and regulatory inspections as needed.
11. Perform other duties as assigned.

What You Will Bring To The Role

• Professional, clear, and consistent communication skills.
• Customer-focused approach.
• Critical thinking skills.
• Positive QA ambassador attitude.
• Effective communication and influence skills.
• Sense of urgency and timely delivery.
• Ability to work independently, take initiative, and be flexible.

Your Experience

• Degree in nursing, biological, physical, health, pharmacy, or related science, with 2+ years of GCP experience.
• Experience with GcLP, GLP, GVP, and GPP is a plus.
• Knowledge of ICH Guidelines, FDA regulations, European Directives, UK Statutory Instruments relevant to GCP.
• Understanding of the Drug Development Process.
• Proficiency with Microsoft Office applications.
• Willingness to travel domestically and internationally (up to 10%).

We believe our work can make lives better. To view other roles, visit our careers page or connect with us on LinkedIn.

Worldwide is committed to diversity, inclusion, and equal opportunity employment, welcoming professionals from all backgrounds.

Additional Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Quality Assurance
• Industry: Research Services

Join us and make a difference!