Senior Director QA Audit and Inspection Program UK REMOTE

JR United Kingdom; West Midlands Combined Authority; Remote; GBP 60,000 - 100,000; Full time

Job summary

An innovative firm is seeking a Senior Director for QA Audit and Inspection Programs to lead strategic initiatives and ensure compliance with quality standards. In this pivotal role, you will manage resources, oversee audits, and drive process improvements while collaborating with cross-functional teams. This position offers the opportunity to impact the lives of patients globally, working with a dedicated team committed to excellence. If you have a passion for quality management and a track record in regulatory compliance, this is the perfect opportunity to make a meaningful difference in the clinical research landscape.

Qualifications

• 7+ years of GCP, GcLP, GLP experience required.
• Experience leading FDA and EMA inspections is essential.
• Strong understanding of risk-based auditing approaches.

Responsibilities

• Lead QA Audit and Inspection Program, reporting to EVP Global Head of Quality.
• Oversee internal and external QA audits, ensuring timely completion.
• Define and report Key Quality Indicators for the Audit & Inspection Program.

Skills

Organizational Leadership

Project Management

Communication Skills

Clinical Research Principles

Risk Management Strategies

Quality Management System Principles

Regulatory Compliance

Auditing Skills

Education

M.S. in a Scientific Field

4-Year College Degree in Related Sciences

Tools

Microsoft Applications

Trackwise

SharePoint

PowerPoint

Job description

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Senior Director QA Audit and Inspection Program UK REMOTE, London (West End)

Client: Worldwide Clinical Trials

Location: London (West End), United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views: 4

Posted: 05.05.2025

Expiry Date: 19.06.2025

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, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What the Senior Director QA Audits and Inspection Programs does at Worldwide

The Sr. Director of QA Audit and Inspection Program is responsible for the strategic vision, oversight, planning, execution, reporting, and quality management of QA Audit & Inspection Program reporting to the EVP Global Head of Quality.

What you will do

• Act as the QA Global head for the QA Audits & Inspections reporting directly to the EVP Global Head of Quality
• Plan, adjust, manage, and optimize all resources (budgets, staff, and technologies) for the advancement of the QA’s goals and objectives for the Audit & Inspection Program
• Oversee, monitor, and report on all internal and external QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements
• Define, monitor, track, and report Key Quality Indicators (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program
• Oversee the management, planning, hosting, reporting, documentation, and follow-up of all GCP Regulatory Inspections and Sponsor audits
• Serve as the Subject Matter Expert on QA Quality Management Processes for Audits and Inspections

What you will bring to the role

• Demonstrates excellent organizational leadership competencies, including scheduling and leading effective, efficient, and well-documented team meetings
• Excellent project management and decision-making skills
• Professional, concise, clear, and consistent communication with external and internal customers, both verbally and in writing
• Strong understanding of clinical research principles and processes for clinical trials
• Ability to work collaboratively with cross-functional stakeholders to drive process improvements based on Quality Indicators
• Experience with risk management strategies implementation
• Previous experience leading/participating in FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, and other international regulatory inspections

Your experience

• Deep understanding of GCP Quality Management System principles
• Knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, AIFA CRO Decree
• Broad experience in quality and regulatory compliance related to GxP activities, specifically GCP
• Knowledge of GcLP, GLP, GVP, GPP, Device, and GMP
• Experience in preparing organizations for GCP Regulatory Inspections and leading GCP Inspections (MHRA, Health Canada, EMA, FDA) in the last 2 years
• Experience implementing GCP inspection readiness activities and tools in the past 2 years
• Proven track record conducting QA Audits (Clinical Investigator, Vendor, Internal Process) in the last 5 years
• Understanding of risk-based auditing approaches
• Experience leading Sponsor Audits independently
• Skills in trending and analysis methodologies
• Knowledge of 21 CFR Part 11 and international guidelines on Electronic Records/Electronic Signatures (ERES)
• Understanding of the Drug Development Process
• Experience managing and complying with annual budgets
• Fluent in English (reading, writing, speaking)
• M.S. in a scientific or health-related field + 7+ years of GCP, GcLP, GLP, GVP, GPP experience OR a 4-year college degree in related sciences + 10+ years of relevant experience, including 8-10 years of managerial experience
• IT proficiency with Microsoft applications, Trackwise, SharePoint, PowerPoint
• Willingness to travel domestically and internationally (~25%)

We love knowing that someone is going to have a better life because of the work we do.

For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.