Senior Director QA Audit and Inspection Program UK REMOTE

JR United Kingdom; Leeds; Remote; GBP 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Director for QA Audit and Inspection Program in a remote role. This position involves leading the QA audits and inspections program, managing resources and budgets, and ensuring compliance with GCP and GxP regulations. The ideal candidate will have extensive experience in clinical research, a strong understanding of regulatory inspections, and exceptional leadership skills. Join a forward-thinking organization committed to improving lives through innovative clinical trials. This is an exciting opportunity to make a significant impact in a dynamic environment.

Qualifications

• 7+ years of GCP, GxP experience in clinical research.
• Proven leadership and project management skills.
• Fluent in English with excellent communication abilities.

Responsibilities

• Lead QA global audits and inspections program.
• Manage resources, budgets, and staff effectively.
• Oversee internal and external QA audits and CAPA completion.

Skills

Leadership

Project Management

Communication Skills

Clinical Research Principles

GCP Processes

Regulatory Inspections

Risk-Based Auditing

Budget Management

Education

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

4-year degree with relevant experience

Tools

Microsoft Office

Trackwise

SharePoint

PowerPoint

Job description

Social network you want to login/join with:

Senior Director QA Audit and Inspection Program UK REMOTE, Leeds, West Yorkshire

Client: Worldwide Clinical Trials

Location: Leeds, West Yorkshire, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views:

19

Posted:

28.04.2025

Expiry Date:

12.06.2025

Job Description:

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, changing the way the world experiences CROs.

Our mission is to work with passion and purpose every day to improve lives.

Why Worldwide

We value diversity, inclusion, collaboration, and creativity. Our workplace thrives on authenticity and excellence. Join us!

Role Overview

The Sr. Director of QA Audit and Inspection Program oversees the strategic vision, planning, execution, and reporting of QA audits and inspections, reporting to the EVP Global Head of Quality.

Key Responsibilities

• Lead the QA global audits & inspections program.
• Manage resources, budgets, staff, and technologies.
• Oversee internal and external QA audits, CAPA completion, and process improvements.
• Define and report on Key Quality Indicators and Tolerance Limits.
• Manage GCP regulatory inspections and sponsor audits.
• Serve as SME on QA processes for audits and inspections.

Qualifications

Essential Skills & Experience

• Leadership, project management, and decision-making skills.
• Excellent communication skills.
• Deep understanding of clinical research principles and GCP processes.
• Experience with FDA, EMA, MHRA, Health Canada inspections.
• Knowledge of GxP regulations, including GCP, GLP, GVP, GPP, GMP.
• Experience preparing for and leading GCP inspections in the past 2 years.
• Proficiency in conducting QA audits (clinical investigator, vendor, internal).
• Understanding of risk-based auditing approaches.
• Ability to manage budgets and speak/read/write English fluently.

Preferred Education & Experience

• M.S. in a scientific or health-related field with 7+ years of relevant GCP, GxP experience.
• OR a 4-year degree with 10+ years of relevant experience and managerial expertise.
• IT proficiency in Microsoft Office, Trackwise, SharePoint, PowerPoint.
• Willingness to travel domestically and internationally (~25%).

We are passionate about making a difference. For more info, visit www.Worldwide.com or connect on LinkedIn.