The Manager, Document Management and Training is responsible for the oversight of the Document Management and Training Management systems and processes. This includes supporting Quality Metric reporting at QMS Boards and Management Review meetings. This role will also support internal audits (related to document and training management), inspection readiness and regulatory authority inspections. In addition, this role will continuously improve GXP Document and Training processes and lead changes in the organization.
Oversee the strategy, development, and management of GxP Document and Training programs and related documentation, ensuring processes, systems, compliance, and content meet regulations, quality standards and business goals
Develop and implement strategic plans for documentation and training
Subject Matter Expert in electronic learning and document management systems managing user support, system improvements, and data
Lead system upgrade and changes by partnering with the vendor and users/business on changes needed to support process and systems improvement as well as validation activities
Oversee and ensure periodic reviews of controlled documents (such as Policy, SOP and Work Instructions) are performed and documented per SOP by working with the GXP business areas
Ensure compliance with legal and regulatory standards for document storage and retention
Oversee company training program partnering with GXP and Non GXP areas, including improving onboarding training experience and process with new employees
Ensure appropriate training requirements are defined in job specific role curriculum/matrix, including gathering training records as requested for audits and regulatory inspections
Oversee, create, implement and manage job specific curriculum/training matrix for GXP functional areas by partnering with GXP Business areas on curriculum training matrix
Assist Quality Management Review for oversight of document revisions, periodic reviews, training assignments, annual curriculum reviews and review metrics performance with this cross functional team
Support inspection readiness activities and regulatory inspections on site and remotely
Bachelor's degree in science or related field with 8 - 10+ years of GxP Quality experience in life sciences industry or equivalent experience
Demonstrated experience in managing pharmaceutical quality systems such as Document Management, Training, Quality Metrics reporting
Experienced in electronic Quality Management and Training Management Systems
Excellent communication and time management skills
Good presentation, verbal and written communication skills
Ability to project manage and lead cross-functional teams in a fast-paced environment
Demonstrated experience in leading, managing and improving pharmaceutical quality systems
Strong leadership, technical, management, problem solving and project management skills
Ability to quickly understand issues, needs and articulate potential solutions in fast paced environment
Manager, Document Control and Training • Boston, MA, United States
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