Manager Documentation Services

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare with leading businesses and products in diagnostics medical devices nutritionals and branded generic medicines. Our 122000 colleagues serve people in more than 160 countries.

Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• 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 bachelors degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.

The Opportunity
This position works out of our Lake Forest IL location in the Core Lab Diagnostics Division. Were empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day more than 10 million tests are run on Abbotts diagnostics instruments providing lab results for millions of people.

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.

What Youll Work On

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

$99300.00 $198700.00

In specific locations the pay range may vary from the range posted.

Quality Assurance

CRLB Core Lab

United States > Lake Forest : CP01

Standard

Yes 5 % of the Time

Not Applicable

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

Manager