Regulatory and Quality Compliance Manager

Job Title: Quality Oversight and Compliance Manager Location: Remote with occasional travel to Walton Oaks or Sandwich Contract: 6 Months 58 per hour SRG are looking for a quality oversight and compliance manager for a global pharmaceutical company. 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. The Quality Oversight and Compliance Manager works closely with the SPACE teams and other stakeholders to identify procedural/compliance gaps and establish and monitor remediation plans to close identified gaps. The Quality Oversight and Compliance Manager supports and drives implementation of initiatives targeting improvements in inspection readiness, audit preparedness and training compliance. The Quality Oversight and Compliance Manager will lead investigations involving process or data deviations and support data gathering, metrics generation and analysis in support of Quality Plans and other compliance initiatives. 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. 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 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. Translates data into information to support the business in taking action and decision making Management of change in partnership with key stakeholders Ability 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 management Relevant knowledge of Pharmaceutical company organizational structure, policies, and practices, with expertise in global regulatory strategy across multiple regions. Proven project management aptitude and ability to quickly learn and use new systems, regulations and quality standards.