Associate Director, Therapeutic Area Quality Lead - Americas / EMEA - Remote

Worldwide Clinical Trials; Valencia; A distancia; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

A global clinical research organization is seeking an Associate Director, Therapeutic Area Quality Lead for the Americas/EMEA, a remote position that involves championing quality assurance practices and compliance. The ideal candidate will have significant experience in GCP and a strong understanding of regulatory guidelines. This role offers a chance to contribute to high-quality standards in a diverse work environment.

Formación

• 5+ years of experience in GCP, GcLP, GLP, GVP, and GPP.
• Broad experience in quality and regulatory compliance related to GxP activities.
• Strong knowledge of QMS, ICH Guidelines, FDA regulations, and European directives.

Responsabilidades

• Champion the adoption of the Quality Management System.
• Provide consultancy and oversight for Quality Issues and CAPA Plans.
• Support risk assessment activities.

Conocimientos

Professional communication skills

Critical thinking skills

Strong influencing and negotiation skills

Educación

M.S. or equivalent in a scientific or health-related field

Bachelor's degree or equivalent

Descripción del empleo

Associate Director, Therapeutic Area Quality Lead - Americas / EMEA - Remote

Join to apply for the 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 persistent diseases is built by those who take pioneering, creative approaches with quality and excellence.

We are Worldwide Clinical Trials, a team of over 3,500 experts, changing the way the world experiences CROs.

Why Worldwide

We believe everyone plays an important role in making a difference for patients. We foster a diverse and inclusive environment where people thrive by being themselves and doing their best work.

What Quality Assurance Does

The QA department sets high standards for quality, exceeding sponsor, participant, and regulatory requirements, and empowering staff to deliver high-quality products.

What You Will Do

• Champion the adoption of the Quality Management System (QMS).
• Provide consultancy and oversight for Quality Issues (QIs) and CAPA Plans.
• Maintain electronic filing for QI and CAPA documentation.
• Act as GCP SME, providing GCP consultancy within the Therapeutic Area (TA).
• Perform TA and study data review and trending activities.
• Support risk assessment activities.
• Provide inspection and audit support as needed.
• Review QMD deviations and QA review of QMDs.
• Manage relationships with Sponsor QA counterparts and oversee quality agreements and metrics.
• Manage business relationships between QA and operational/TA leadership.
• Assist with Sponsor audits and regulatory inspections.

What You Will Bring To The Role

• Professional communication skills, both verbal and written.
• Customer-focused approach.
• Critical thinking skills.
• Ability to plan, manage, and optimize resources.
• Experience managing complex projects and teams.
• Independent work ethic, initiative, and flexibility.
• Strong influencing and negotiation skills.

Your background

• M.S. or equivalent in a scientific or health-related field with 5+ years of GCP, GcLP, GLP, GVP, and GPP experience.
• Bachelor’s degree or equivalent with 7+ years of relevant GCP, GLP, GVP experience.
• Broad experience in quality and regulatory compliance related to GxP activities, especially GCP.
• Strong knowledge of QMS, ICH Guidelines, FDA regulations, European directives, and UK statutes relevant to GCP.
• Understanding of drug development processes.
• Experience supporting regulatory inspections is a plus.
• Willingness to travel domestically and internationally (up to 15%).

We are committed to diversity and inclusion, providing equal employment opportunities to all employees and applicants regardless of race, gender, age, disability, or other protected status.

Additional Information

Seniority level: Director

Employment type: Full-time

Job function: Quality Assurance

Industries: Research Services