Job
Description
The Global Supply Chain Compliance Manager plays a crucial role in ensuring GxP compliance within the Global Supply Chain (GSC) by providing operational support for the Quality Management System (QMS) and actively participating in various business activities. An integral part of this role is to identify and support process improvements to enhance overall compliance and efficiency. Key responsibilities of the role include managing Global Supply Chain compliance, monitoring process performance, conducting trend analysis, and ensuring audit readiness. The Manager is also tasked with developing effective training strategies to enhance team capabilities. Additionally, document management on the Electronic Document Management System (EDMS) and serving as a functional expert and advisor are essential aspects of this role. Collaboration with various GSC functions is a critical component of maintaining GxP compliance and supporting business activities in alignment with procedural requirements. The Manager serves as an advisor and functional expert, drawing upon a wealth of knowledge and experience in their specialized area. Working closely with GSC Global process owners, the Manager contributes to the design, management, and improvement of capabilities to drive operational excellence. Participation in the development and implementation of training strategies is vital for achieving consistency and compliance standards within the organization. The Manager is responsible for delivering training sessions as needed and supporting the creation of procedures to enhance efficiency, effectiveness, and alignment with strategic objectives. Monitoring compliance, reporting performance metrics, and conducting trend analysis for processes are integral parts of the role. Document and record management on EDMS, cross-functional collaboration to support compliance activities, and ownership or support for eQMS records such as deviations, change controls, CAPAs, and risk assessments are key responsibilities. The Manager also plays a pivotal role in supporting audit readiness to ensure GSC functions are well-prepared and compliant. Executing self-inspections, participating in process/system enhancements, and providing timely communication on compliance risks/issues are essential duties. The GSC Compliance Manager may be assigned delegated responsibilities for eQMS activities, such as being an Infinity change owner or deviation owner, to support various GSC roles like Market Supply Orchestrator or Finished Good Planner. Essential Skills and Qualifications: - Excellent interpersonal and communication skills - Proficiency in technical writing - Strong time management and organizational abilities - Capacity to handle multiple projects simultaneously - Proactive approach and ability to achieve targets - Flexibility, motivation, and adaptability - Data analysis skills - Sound Supply Chain knowledge - Confident public speaking skills - Problem-solving skills for routine issues Education: Bachelor's degree in Supply Chain, Engineering, or a related Scientific/Technical discipline Desired Experience/Knowledge: - More than 5 years of experience in compliance and/or quality assurance roles - Familiarity with GDP/GMP and e-Quality Management systems (eQMS) like Veeva Vault - Experience in Supply Chain operations - Background in working within a highly regulated environment - Experience in cross-functional collaboration to develop systems and standard ways of working, digitized metrics, and reporting This role may involve up to 10% travel as part of its responsibilities.,
