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

Worldwide Clinical Trials; North Carolina; Remote; USD 100,000 - 130,000; Full time

Job summary

Join a global CRO as an Associate Director, Therapeutic Area Quality Lead, focusing on quality assurance and regulatory compliance. The role involves championing quality management systems, providing oversight on quality issues, and ensuring compliance with GCP and GxP standards. You will work closely with project teams and sponsor QA teams to maintain high-quality standards in clinical trials.

Qualifications

• 5+ years of GCP, GxP experience.
• 7+ years of relevant experience for Bachelor's degree holders.

Responsibilities

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

Skills

GCP

GxP

Quality Management

Regulatory Compliance

Drug Development

Education

MS or equivalent in a scientific or health-related field

Bachelor’s degree

Job description

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

Join our team as an Associate Director, Therapeutic Area Quality Lead - Americas/EMEA - Remote at Worldwide Clinical Trials.

Who We Are
We are a global, midsize CRO committed to innovation and excellence in the pursuit of cures for persistent diseases. Our team of over 3,500 experts is dedicated to changing the way the world experiences CROs, emphasizing quality, creativity, and collaboration.

Why Choose Worldwide
We value diversity and inclusion, fostering an environment where everyone can thrive. Our culture promotes collaboration, creativity, and the success of our employees, enabling them to do their best work every day.

Role Overview
The Quality Assurance department at Worldwide sets high standards for quality, exceeding sponsor, participant, and regulatory expectations. We empower our staff through training and a quality-focused culture.

Key Responsibilities

• Champion the adoption of the Quality Management System (QMS).
• Provide consultancy and oversight for Quality Issues (QIs) and CAPA Plans.
• Maintain electronic documentation for QI and CAPA activities.
• Act as GCP Subject Matter Expert, offering consultancy to project teams within your Therapeutic Area.
• Review and analyze study data and trends.
• Support risk assessment activities.
• Assist with site inspections and audits as needed.
• Review and approve Quality Management Documents (QMDs).
• Manage relationships with Sponsor QA teams, including quality agreements and metrics.
• Coordinate with operational and TA leadership.
• Support sponsor audits and regulatory inspections.

Qualifications

• MS or equivalent in a scientific or health-related field with 5+ years of GCP, GxP experience.
• Bachelor’s degree with 7+ years of relevant experience.
• Broad knowledge of quality and regulatory compliance, especially GCP.
• Strong understanding of drug development and GxP principles.
• Experience supporting regulatory inspections is a plus.
• Willingness to travel domestically and internationally (up to 15%).

Join us in making a difference in patients' lives. Learn more about our roles at our careers page or connect with us on LinkedIn. We are an equal opportunity employer committed to diversity and inclusion.