Manager, Document Control and Training

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