Associate Director Of GCP Quality Assurance

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Job description

Our client is a leading pharmaceutical specialist who have a new role as the SME for GCP Quality Assurance. The role is a stand alone role reporting into the head of quality. They are looking for someone with at least 8 years of clinical quality assurance to work in their QA team of around 10.
The role is based in London and offer hybrid working model.
Raise the profile of the GCP function and promote a culture of a 100% Compliance mind-set within the organisation
Responsible for designing, setting up, maintaining and executing robust GCP compliance programs for both Local and Global GCP Audit Programs including proper management of audit schedules and execution of audits, ensuring compliance with regulatory standards, company policies, and procedures.
Ensure the timeliness and completeness of reports and assessment of appropriate CAPAs.
Serve as a subject matter expert by providing high standard of quality guidance, advice and support on GCP compliance.
Contribute to the development of global and local quality management systems, including contributing/writing or reviewing policies/procedures.
Partner with Quality Systems or Good Manufacturing / Distribution practice (GMDP) groups to develop and enhance the GxP Quality Management System, looking for cross-GxP efficiencies and synergies.
Manage and perform/handle GCP investigations regarding Clinical Quality Issues, Misconduct Investigations including Serious Breaches etc.
Manage and identify potential systemic compliance risks including Investigations of deviations and monitoring of corrective actions and preventative (CAPA) relating to non-compliance issues and findings.
Establish and maintain GCP regulatory inspection and audit readiness.
Manage, host and participate in preparation and execution of regulatory agency inspection activities.
Support the development and delivery of GCP training programs.
Lead development of process improvement strategies and tools related to GCP compliance efforts.
Assist with Clinical activities (e.g. deviations, CAPAs) when requested.
Ensure key performance indicators for GCP are set-up, maintained, performed and reported to detect and monitor any significant compliance deviations to the company quality standards and/or regulatory requirements
Maintain ongoing expert knowledge of regulations, company procedures, auditing, and quality principles.
Facilitate the sharing of best practices and help to drive continuous improvement and compliance.
Continuously build and innovate in all aspects of GCP compliance
Perform other quality or compliance related duties as needed.
Please contact for more info