Manager, Document Control and Training

About the role

The Manager, Document Management and Training oversees the Document Management and Training Management systems and processes, including supporting Quality Metric reporting at QMS Boards and Management Review meetings. This role supports internal audits related to document and training management, inspection readiness, and regulatory authority inspections, while continuously improving GXP Document and Training processes and leading organizational changes.

Responsibilities

• Develop and implement the strategy, management, and oversight of GxP Document and Training programs, ensuring compliance with regulations, quality standards, and business goals.
• Create and execute strategic plans for documentation and training as a Subject Matter Expert in electronic learning and document management systems, including user support, system improvements, and data management.
• Lead system upgrades and changes by partnering with vendors and business users to support process improvements and validation activities.
• Oversee and ensure periodic reviews of controlled documents (e.g., Policy, SOP, Work Instructions) are performed and documented per SOP in collaboration with GXP business areas.
• Ensure compliance with legal and regulatory standards for document storage and retention.
• Oversee the company training program, partnering with GXP and Non-GXP areas to improve onboarding training experiences and processes for new employees.
• Define training requirements in job-specific role curricula/matrices and gather training records for audits and regulatory inspections.
• Create, implement, and manage job-specific curricula/training matrices for GXP functional areas in partnership with GXP business areas.
• Support Quality Management Review for oversight of document revisions, periodic reviews, training assignments, annual curriculum reviews, and metric performance with cross-functional teams.
• Support inspection readiness activities and regulatory inspections on-site and remotely.

Requirements

• Bachelor’s degree in science or a related field with 8–10+ years of GxP Quality experience in the life sciences industry or equivalent experience.
• Demonstrated experience managing pharmaceutical quality systems such as Document Management, Training, and Quality Metrics reporting.
• Experience with electronic Quality Management and Training Management Systems.
• Strong leadership, technical, management, problem-solving, and project management skills.
• Ability to project manage and lead cross-functional teams in a fast-paced environment.
• Excellent presentation, verbal, and written communication skills.
• Ability to quickly understand issues, assess needs, and articulate potential solutions in a dynamic environment.