Doc Center Supervisor

PURPOSE STATEMENT

Supervise the Document Control Department in Costa Rica to ensure an efficient consistent operation aligned with AbbVies 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 AbbVies 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 teams 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 positions 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 AbbVies culture are reinforced and recognized in a timely manner both formally and informally.

Qualifications :

EDUCATION

• University bachelors degree in a STEAM-related field preferably Industrial Engineering Business Administration English or English Teaching. A masters degree in a related field is preferred.

• Advanced English proficiency in reading comprehension writing and conversation. C1 level or higher preferred.

EXPERIENCE

• 3 years of experience in quality systems compliance traceability risk management and change control within a regulated industry preferably under ISO 13485.

• Experience working with cross-functional teams to ensure timely execution standardization and compliance.

• Experience in project management audits inspections or process improvement.

• Experience with electronic documentation systems such as SAP OneVault Salesforce Arena Windchill or similar platforms.

SKILLS

• Ability to supervise coordinate and follow up on team activities and priorities.

• Strong interpersonal analytical communication and negotiation skills.

• Ability to organize prioritize and follow up on multiple processes and stakeholders.

• Knowledge of change control filing and critical documentation processes associated with medical devices.

• Continuous improvement and problem-solving mindset.

• Ability to work collaboratively with multidisciplinary teams.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time