Operational Compliance and QA Manager

2 weeks ago


London, United Kingdom Worldwide Clinical Trials Full time

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.


Why Worldwide


What a Regulatory Compliance Quality Operations Manager does at Worldwide


Reporting to the Director Regulatory Compliance Quality Operations, the Regulatory Compliance Quality Operations Manager is responsible for regulatory compliance quality operational oversight of GxP Quality activities. Provide assurance with SOPs, Regulations, and guidelines for Worldwide processes in collaboration with functional areas. Including managing Quality Issues and CAPA’s, supporting audits and inspections at Worldwide, conducting/oversight of audits of Worldwide vendors and QA oversight of contracts and quality agreements.


Conduct regulatory intelligence/surveillance for GxP requirements globally. Identify quality impact and actions and advise on requirements for Worldwide systems, processes and training.
Facilitate Identification, and guide continuous improvement in GxP compliance for Worldwide processes, operations and systems.
Responsible for the GxP compliance of key Worldwide activities including oversight of vendors activities.
Perform audits and participate in inspections to ensure GxP compliance and ensure observations are reported and CAPA plans implemented to provide assurance of compliance with processes, regulations, guidelines, and agreements. Provides QA GxP consultancy to the Worldwide operations relating to compliance requirements.

Engagement and interest in GxP regulations, laws and guidelines with an ability to share and coach.
Fluency in English (speaking, reading, and writing)
Proficiency in Microsoft applications (Excel, Word, eQMS, PowerPoint)

Bachelor's degree or equivalent in a relevant field (e.g., Science, Computer Science or other related science) and minimum 4 years of experience in a GxP regulated environment (monitoring, data management, PV, clinical trial management, clinical system validation)
At least 2 years of experience in quality or regulatory compliance roles for GxP activities (including for example, QA audits, noncompliance investigations)
Previous experience participating in regulatory inspections (FDA, MHRA, Health Canada, EMA)
Excellent working knowledge of Quality Management Systems, ICH Guidelines, FDA regulations, European Regulations and Directives, MHRA Statutory Instruments related to relevant GxP.

To view our other roles, check out our careers page at For more information on Worldwide, visit or connect with us on LinkedIn.
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