Director, Quality and Risk Management

4 weeks ago


City of London Greater London, United Kingdom Proclinical Staffing Full time

Proclinical is seeking a dedicated and experienced Director of Clinical Quality. This role is pivotal in developing and implementing quality assurance strategies that support our clinical portfolio. The successful candidate will be responsible for establishing effective GCP QA audit programs and systems that support clinical trials. This role can be home-based within the United Kingdom or can be a hybrid working role or full office working role within the London office. Develop and implement GCP risk-based processes and frameworks for vendor and system oversight
Define and build the GCP QA strategy to support our clinical portfolio
Develop and deliver ongoing GCP training
Manage audits of sites, documents, databases, vendors, or internal systems in compliance with GCP and quality standards
Assess impact of audit findings and escalate compliance risks as needed
Support clinical quality champions in implementing corrective and preventive actions
Lead investigations into significant quality issues, scientific misconduct, and serious breach of GCP
Present clinical metrics and escalate systemic and/or critical problems to management
Experience with GXP QA systems, processes, and procedures
Bachelor's degree in a scientific discipline or equivalent combination of education and experience
Relevant experience in a GCP audit biotech/pharmaceutical setting
Ability to understand quality issues in a complex and highly regulated environment



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