Job Title

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 PurposeThe 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 ResponsibilitiesIdentifies 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 initiativesTechnical Skill RequirementsExperience in leading investigations and managing CAPA plansStrong knowledge of the drug development process, Regulatory Affairs, Regulatory Strategy and Submissions Management.Proven fluency with use of soft skills and ability to adapt core project management skills successfully within a dynamic line environment.Understanding of systems and electronic technologies used to support regulatory and submission process and planning activities and experience in process development and new technology implementation.Translates data into information to support the business in taking action and decision making Ability to transform ambiguous situations/discussions into structured outcomesManagement of change in partnership with key stakeholdersAbility to lead and operate seamlessly to influence colleagues across the organization and ensure delivery to time and quality driving highly complex projects to meet evolving business needs.Proven aptitude in project managementIf this is something you'd be interested in, send your CV to jamie.keith@cpl.com.