Manager Documentation Services

Abbott • Lake Forest, CA

2d • Onsite

About The Position

The Manager Documentation Services is responsible for leading and executing documentation management activities that support new product development and manufacturing operations. Oversees document control, change management, design and drafting, and technical publications while ensuring compliance with FDA, GMP, ISO, and other global regulatory requirements. Serves as a key leader in the implementation and maintenance of the Electronic Document Management (EDM) program, coordinates documentation efforts for new product introductions, and provides support to division-wide documentation systems. Partners closely with Quality, Manufacturing, Development, and Legal teams to drive compliant documentation practices, operational excellence, and successful business outcomes.

Requirements

• Bachelors degree in Engineering, Science, or a related field, or an equivalent combination of education and work experience.
• Minimum 10 years progressively more responsible documentation management experience including broad knowledge in the field of new product introduction, drafting and electronic data management is required.
• Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position.

Nice To Haves

• Must be skilled at delegation, follow-up, database management tools, document control procedures, and team building
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.

Responsibilities

• Manages the daily activities of the department by establishing priorities, work schedules, problem solving, and customer service.
• Setting goals ensures that they are met and are responsible for continuous process improvement.
• Ensures employee compliance with Abbott and Division policies.
• Defines and allocates resources needed to meet established project schedules.
• Exercises judgment in planning and organizing work; monitors performance and reports status.
• Develops and controls department budget.
• Ensures documentation activities are in compliance to ISO and 21CFR 820 Quality System Regulation.
• Developing process flows to coordinate documentation change control activities between facilities in the globally.
• Conducts research for Legal Department during litigation.
• Responsible for maintenance and control of Device Master Record.
• Provides documents and history records regarding Device Master Records during regulatory audits.
• Troubleshoots, resolves, and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback.
• Maintains a safe and professional work environment.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager