PURPOSE STATEMENT
Supervise the Document Control Department in Costa Rica to ensure an efficient, consistent operation aligned with AbbVie’s corporate standards, while ensuring the timely fulfillment of Quality System requirements and applicable regulatory requirements. Lead the creation, approval, maintenance, and custody of controlled documentation for medical products, as well as the administration of the change control system and document repositories. Drive continuous improvement of documentation and training processes, systems, and metrics, strengthening operational effectiveness and compliance across AbbVie’s different sites.
MAJOR RESPONSIBILITIES
Supervise and coordinate the activities of the Document Control Department, ensuring the timely and consistent execution of the processes under its responsibility.
Assign, prioritize, and follow up on the team’s work to ensure compliance with Quality System requirements and applicable regulatory requirements.
Ensure the custody, control, filing, retrieval, reproduction, distribution, and traceability of controlled documentation, including related documents, records, and logs.
Coordinate and follow up on the administration of the Change Control Board, ensuring compliance with established guidelines, traceability of changes, and timely closure of outstanding items.
Supervise the complete document control process, including DCC, ECO, and MCO, ensuring document consistency and integrity, as well as compliance with internal procedures.
Follow up on the preparation, organization, and documentation required for internal and external audits, as well as the timely closure of findings, CAPAs, and investigations assigned to the department.
Monitor departmental metrics, indicators, and results, identifying trends, improvement opportunities, and operational support needs.
Coordinate the implementation and effective use of manual and electronic documentation and training systems, ensuring adoption, consistency, and operational stability.
Support coordination with other functional areas to address requests related to critical documentation, changes, training, and support for improvement initiatives.
Promote continuous improvement of Document Center processes by driving standards, operational efficiency, and sustained compliance.
Participate in process improvement or new product introduction projects with the objective of identifying and coordinating the activities required of the Document Center.
Define and control the budget for the areas under the position’s responsibility.
Perform other duties inherent to the position and any additional responsibilities assigned by the immediate supervisor.
Foster the motivation of direct reports by ensuring that behaviors promoted by AbbVie’s culture are reinforced and recognized in a timely manner, both formally and informally.