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

Worldwide Clinical Trials; Lasalle; Remote; CAD 100,000 - 130,000; Full time

Job summary

A global CRO is seeking an Associate Director, Therapeutic Area Quality Lead for the Americas/EMEA region. This remote role involves championing quality management systems, providing oversight for quality issues, and ensuring compliance with regulatory standards. Join a diverse team committed to innovation and high-quality standards in drug development.

Qualifications

• 5+ years of relevant GCP, GcLP, GLP, GVP, and GPP experience.
• 7+ years of relevant GCP, GLP, GVP experience.

Responsibilities

• Champion the adoption of the Quality Management System (QMS).
• Provide consultancy and oversight for Quality Issues (QIs) and CAPA plans.
• Support risk assessment processes within Risk Based Quality Management.

Skills

GCP

Quality Management Systems

Regulatory Compliance

Drug Development Processes

Education

MS or equivalent in a scientific or health-related field

Bachelor’s degree or equivalent

Job description

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

Join us at Worldwide Clinical Trials as the Associate Director, Therapeutic Area Quality Lead - Americas/EMEA - Remote.

About Us

We are a global, midsize CRO dedicated to innovation and excellence in the pursuit of cures for persistent diseases. Our team of over 3,500 experts is committed to changing the way the world experiences CROs by taking pioneering and creative approaches.

Why Join Us

We value diversity, inclusion, and collaboration, fostering an environment where everyone can thrive. Our culture emphasizes high-quality standards, continuous improvement, and making a difference for patients and caregivers worldwide.

Role Overview

The Quality Assurance department at Worldwide sets high standards for quality, exceeding sponsor and regulatory requirements. We empower our staff to deliver exceptional products and services.

Key Responsibilities

1. Champion the adoption of the Quality Management System (QMS).
2. Provide consultancy and oversight for Quality Issues (QIs) and CAPA plans.
3. Maintain electronic filing for QI and CAPA documentation.
4. Serve as GCP Subject Matter Expert, offering GCP consultancy to project teams within the Therapeutic Area (TA).
5. Perform TA and study data review and trending activities.
6. Support risk assessment processes within Risk Based Quality Management.
7. Assist with Clinical Investigator Site inspections and audits.
8. Review QMD deviations and QA documents during revisions or review cycles.
9. Manage relationships with Sponsor QA counterparts, including quality agreements and metrics.
10. Oversee the business/operational relationship between QA and TA/operational leadership.
11. Support sponsor audits and regulatory inspections as needed.

Qualifications

• MS or equivalent in a scientific or health-related field with 5+ years of relevant GCP, GcLP, GLP, GVP, and GPP experience.
• Bachelor’s degree or equivalent with 7+ years of relevant GCP, GLP, GVP experience.
• Broad understanding of quality and regulatory compliance related to GxP activities, especially GCP.
• Strong knowledge of Quality Management Systems, ICH Guidelines, FDA regulations, European Directives, and UK Statutory Instruments.
• Excellent understanding of drug development processes.
• Experience supporting regulatory inspections is a plus.
• Willingness to travel domestically and internationally up to 15%.

Additional Information

We are committed to diversity and inclusion, providing equal opportunities for all employees and applicants. Join us in making a difference and advancing your career in a collaborative and innovative environment.