Mantell Associates is currently partnered with a well-established Pharmaceutical organisation, who is seeking an experienced Remediation Consultant to join their team on a contract basis.
In this role you will lead quality remediation initiatives and corrective action programmes to support operational compliance and regulatory readiness.
Remediation Consultant - Responsibilities:
* Lead and manage remediation projects across manufacturing operations, focusing on system improvements, process compliance, and GMP alignment
* Review and overhaul quality systems including deviations, CAPA, change control, and document management to ensure sustained regulatory compliance
* Conduct root cause investigations of non-conformances and quality events; develop and oversee implementation of robust corrective and preventive action programmes
* Collaborate with cross-functional stakeholders - Quality, Manufacturing, Engineering, Validation, Regulatory Affairs - to implement remediation plans and monitor progress
* Support readiness for regulatory inspections (MHRA/EMA) and internal audits through thorough gap assessments, remediation tracking, and documentation support
* Deliver regular status updates, risk reports and KPI dashboards to senior leadership, highlighting issues, mitigation actions and remediation outcomes
Remediation Consultant - Requirements:
* Extensive experience in quality assurance, remediation or operational excellence roles within pharmaceutical manufacturing (GMP environment)
* Proven track record managing remediation or recovery programmes, working with contractors/vendors and internal teams to drive compliance improvements
* Strong knowledge of GMP regulations (UK/EU), quality systems, deviation management, CAPA, change control and inspection readiness
* Excellent communication, stakeholder management and project leadership skills - able to operate across multiple sites and functional areas
* Based in the UK, eligible to work full-time on a contract basis, with remote capability and willingness for periodic on-site work
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.