Document Control Manager

Summary:

The Document Control Manager will oversee the document control program, including managing the document review process and accompanying system, facilitating change requests, creating training materials, and supporting the organization’s compliance programs. Additionally, the Document Control Manager will manage the relationship with translation vendor(s) and support the development of new document control processes in compliance with regional regulations.

 Key Deliverables:

• Document module in Quality Management System (QMS)
• Document Creation & Revision
• Change Requests
• Training resources
• Translation management

 Specific Duties/Responsibilities: 

• Oversee the document control program by supporting document creation, revision, and archiving processes.
• Manage the document module in the Quality Management System, including configuration, staff training, and reporting.
• Collaborate with teams to develop effective training programs, including training documents and effectiveness checks.
• Work closely with the Legal & Regulatory Affairs teams during the document publication process to ensure compliance with regulatory requirements.
• Develop and maintain new document control programs in support of Direct Relief’s regional growth.
• Develop and oversee the implementation of translation policies and processes, including translation vendor management.

 Skills, Attributes, and Qualifications:

Skills:

• Proficient in working with Microsoft Word, Excel, Visio, PowerPoint, and SharePoint.
• General knowledge of electronic quality management systems, ERP systems (SAP preferred), computer-based management systems, and application of FDA regulations for applicable products preferred. 
• Experience with system and process implementation.
• Strong system troubleshooting capability
• Ability to apply Good Documentation Practices and regulatory requirements into user-friendly documentation and associated processes.
• Knowledge of best practices for employee training programs.

 Attributes:

• Must have a collaborative work style.
• Must possess strong analytical and problem-solving skills.
• Must be a team player with strong verbal and written communication skills.
• Must have a commitment to high standards of professionalism and integrity.
• Must be patient and work with users to help them understand and learn concepts at a pace that matches individual skills.
• Ability to work independently with minimum supervision.
• Detail oriented with the ability to take initiative and work independently.

 Qualifications: 

• Knowledge of and experience in an FDA-regulated industry required with a sound understanding of Good Distribution Practices and Good Documentation Practices.
• Solid working experience in a position related to Quality Management Systems, including good understanding of requirements for documentation and training management in GxP environment.
• Good working business process knowledge of procurement, operations, warehousing, and order fulfillment.
• Bachelor’s Degree
• 5 Years of related experience.