Sr. Manager / Associate Director Document & Change Mangement

Job Description

Job Description

Sr. Manager / Associate Director Document & Change Management Allendale, NJ The Senior Manager Documentation & Change Management will assist with the overall leadership and implementation of global Document Management and Control and the Change Control Management program designed to comply with applicable laws and regulations. This position has accountability for development and oversight of global quality documents, the structure of the program, and the design, implementation and continuous improvement of electronic document management systems. This position also has responsibility for oversight of the regional Change Management system and accountability for the design, implementation, administration, and continuous improvement of the electronic change management system.

• Responsible for the development of systematic control and management processes for GxP documents throughout their lifecycle and for establishing procedures to ensure records (paper and electronic) are maintained in compliance with global regulatory and legal requirements, as well as site requirements and procedures.
• Responsible and accountable for the development, deployment and implementation of effective and efficient standards, procedures, and best practices for global and site documentation management and control including periodic review, change process, retention and archival.
• Maintains the global Quality Manual and global Quality Standards, and any associated global policies, reports, or documents.
• Assists in developing the overall global Quality Standards strategy and implementing the quality documentation hierarchy for global and site documentation, including development of process for gap assessments and implementation planning.
• Engages process owners and SMEs to ensure quality standards are appropriately defined, implemented, and / or updated to include current regulatory strategy and are contemporaneous with industry standards.
• Leads the development of reporting on quality standards implementation across all functions.
• Accountable for development and management of effective documentation system KPIs, metrics, management review, and proactive issue identification and resolution.
• Partners, educates, and collaborates with Documentation Control, QA, and SOP authors / owners in other functional areas for the development, deployment and maintenance of the document management program and records retention schedule.
• Business process owner for the electronic documentation management system. Partner with IT to implement, administer, maintain, and continuously improve the electronic documentation management system.
• Manages the document change request system at the global and regional level and provides guidance at the site level.
• Provides support during internal and external audits, including Regulatory Health Authority inspections.
• Ensures the documentation system is scalable and flexible to support initiatives and communicates effectively with all cross functional and regional stakeholders on matters related to the documentation system and e-DMS.

Change System Management :

REQUIREMENTS

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.