AbbVie · Chicago
OtherFull-time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
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.
EDUCATION
University bachelor’s degree in a STEAM-related field, preferably Industrial Engineering, Business Administration, English, or English Teaching. A master’s 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.
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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html