Jobs in Sandwich, kent, uk

I am looking to speak with Quality & Compliance Managers looking for their next contract opportunity with a Global Pharmaceutical Manufacturing organisation based out of Sandwich, Kent.

This position reports to the Regulatory Quality Oversight Lead for Submission Process & Compliance Excellence, Submissions Management and works with GRS BU Regulatory Strategy (above country and in country), Global CMC, Regulatory Operations, Safety and Regulatory Quality, Information Management, COE SOP & Training, appropriate governance and advisory bodies and external vendors if applicable.

Position Purpose

The Quality Oversight and Compliance Manager will be responsible for driving improvements to existing processes, supporting implementation and monitoring of initiatives related to pan-regulatory (e.g. Manufacturing, Regulatory Strategy, CMC, Submissions, Translation) information and processes globally through data reporting / metrics analysis. The Quality Oversight and Compliance Manager works with global delivery teams to improve the quality and compliance associated with regulatory processes and product / license information.

Primary Responsibilities

• Identifies opportunities for improvement of pan-regulatory data and business processes and procedures, through the collection and analysis of metric data in collaboration with Information Management, Analytics + Reporting, business process owners and other stakeholders.
• Provides accurate and detailed reports and presentations on the above activities for senior management, Quality councils and governance committees as required including executive summaries to Senior Management.
• Identifies procedural / compliance gaps associated with in scope processes and establishes mitigation and remediation plans with business process owners that provide optimal balance of compliance and business need.
• Provides support to stakeholders in ensuring inspection readiness, preparing for audits / inspections and provide remediation support for audit (or inspection) findings.
• Participates on cross functional teams to execute quality improvements.
• Leads / provides input to the investigation of suspected Quality Events (QEs), Corrective / Preventative Action (CAPA) plans and audits / inspections and owns resulting actions as appropriate.
• Generates metrics and data analysis in support of Quality Plans and other compliance initiatives

Technical Skill Requirements

If this is something you'd be interested in, send your CV to [email protected].