Quality Oversight and Compliance Manager

CK Group are recruiting for a Quality Oversight and Compliance Manager to join a company in the pharmaceutical industry on a contract basis for 6 months initially.Salary: PAYE 23.39 - 28.59 per hour or UMB 26.21 - 32 per hour (inside IR35). Quality Oversight and Compliance Manager role:Responsible for driving improvements to existing processesSupports 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.Works with global delivery teams to improve the quality and compliance associated with regulatory processes and product/license informationIdentifies procedural/compliance gaps and establish and monitor remediation plans to close identified gapsSupports and drives implementation of initiatives targeting improvements in inspection readiness, audit preparedness and training compliance Your Background:Experience in leading investigations and managing CAPA plans Strong 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. ..... full job details .....
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