Job Description:

• Support development, implementation and management of Quality Management System (QMS) and related
• processes to ensure adherence to regulatory and Client requirements.
• Collaborate with Global Quality Organizations to identify and implement system enhancements.
• Participate in testing and verification of new and revised system functionality/enhancements.
• Enter and update system list of values timely, as needed.
• Support testing and training activities as needed for system implementations and or enhancements.
• Work cross-functionally to support the creation and revision of policies and procedures in support of Client Quality Systems.
• Manage user change requests and change process.
• Gather user requirements and work with technical personnel to define the appropriate configuration for IT Systems to meet defined business requirement.
• Consult with management and business process owners to ensure QMS system is aligned with user requirements
• Create reports and metrics for users.
• Provide regular updates on project progress and escalate challenges as needed.
• Train end users on the use of new and updated Quality business process, system, policies and procedures.
• Other duties as assigned

Other Qualifications:

• Understanding of Quality best practices, including familiarity with Quality Systems Regulations, GxPs, and applicable ISO Standards
• Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs).
• Excellent attention to details
• Ability to effectively manage time and progress tasks to meet timeline in a fast pace/dynamic environment
• Effective oral and written communication skills
• Experienced working cross-department with Quality, IT, Clinical, Regulatory and Development.
• Working knowledge of business process and process improvement
• Experienced interfacing with external software vendors.
• Experienced in managing projects towards process improvements.