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

Worldwide Clinical Trials; United Kingdom; Remote; GBP 70,000 - 90,000; Full time

Job summary

Join a global CRO as an Associate Director, Therapeutic Area Quality Lead. You will champion quality management, oversee quality issues, and ensure compliance with regulations. This remote role offers the chance to make a significant impact in clinical trials.

Qualifications

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

Responsibilities

• Champion the adoption of the Quality Management System (QMS).
• Provide consultancy and oversight for Quality Issues (QIs) and CAPA Plans.
• Manage QA relationships with Sponsor QA counterparts.

Skills

Quality Management Systems

GCP

Regulatory Compliance

Risk Assessment

Education

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

Bachelor’s degree in biological, physical, health, pharmacy, or related sciences

Job description

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

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

About Us
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 by taking pioneering and creative approaches.

Why Join Us
We value diversity, inclusion, and collaboration, fostering an environment where everyone can thrive and do their best work. Our culture emphasizes quality, passion, and purpose in improving lives.

Role Overview
The Quality Assurance department at Worldwide sets high standards for quality, exceeding sponsor, participant, and regulatory expectations. We empower staff to deliver high-quality products through training and a supportive environment.

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 up-to-date electronic documentation for QI and CAPA activities.
4. Act as GCP SME, offering consultancy to project teams within the assigned Therapeutic Area (TA).
5. Perform TA and study data review and trending activities.
6. Support risk assessment processes in collaboration with Risk-Based Quality Management.
7. Provide support for Clinical Investigator Site inspections and audits.
8. Review QMD deviations and provide GCP consultancy within the SME area.
9. Review Quality Management Documents (QMDs) during revisions or regular cycles.
10. Manage QA relationships with Sponsor QA counterparts, including quality agreements and metrics.
11. Manage the operational relationship between QA and TA/operational leadership.
12. Assist with Sponsor audits and regulatory inspections as needed.

Qualifications and Experience

• M.S. 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 in biological, physical, health, pharmacy, or related sciences with 7+ years of relevant experience.
• Broad understanding of quality and regulatory compliance related to GxP activities, especially GCP.
• Excellent knowledge of Quality Management Systems, ICH Guidelines, FDA regulations, European Directives, and UK Statutory Instruments 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 creating an inclusive environment and are proud to be an equal opportunity employer.