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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.
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