Abbott Sr. Manager, Quality System and Compliance in Irving, Texas

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Summary:

Oversee and provide direction for the Dallas Site quality systems. Establish strategic direction. Develop long term

strategies to meet Divisional and Site goals. Coordinate a broad; multi-disciplined work unit.

Accountable for achievement of compliance; financial; and performance goals. Responsible for establishing;

monitoring; and maintaining the quality system.

Main Responsibilities:

  • Responsible for implementing and maintaining the effectiveness of the quality system.

  • Manages site compliance organization. Develops a successful compliance strategy that supports Abbott's

  • growth objectives. Develops the annual audit schedule for the Dallas site in accordance with the Division audit

  • schedule. Assigns audit support personnel based on audit schedule and the agreement of site management.

  • Must be able to oversee the assimilation of new regulations to assure compliance; must be perceptive to ADD

  • management directives; and the current regulatory climate; and be able to realistically assess business risks.

  • Manages the interface with all regulatory agencies to assure that compliance and satisfactory regulatory

  • relationship are maintained.

  • Responsible for keeping "Audit Readiness Scorecard" and reviewing with site leadership.

  • Continuously identify and drive improvements to the quality system.

  • Facilitates Executive Management Review meetings. Develops; implements; and maintains an effective

  • Quality data collection and information reporting system. Assures that this system provides timely identification

  • and reporting of product problems associated with incoming; in-process; and finished product (as appropriate

  • by product).

  • Is Deputy Management Representative in the absence of the Site Quality Director.

  • Manages the documentation control organization; including responsibility for releasing the instrument DMR.

  • Liaison with Division QSR and responsible for assessing impact of new or changing division policies;

  • processes and procedures with Dallas Quality System.

  • Responsible for Dallas Quality System Manual.

  • Must effectively communicate; prepare; and negotiate both internally with ADD personnel and externally with

  • various regulatory agencies;

  • failure to do so will have direct impact on market entry dates and market presence for new product.

  • May also manage other quality system organizations; such as the centralized Corrective Action and

  • Preventive Action (CAPA) group; Non-Project Software; etc.

Qualifications:

Bachelors Degree. Experience with external audit agencies. Experience in development of quality system procedures. A

minimum of 5 years’ experience in a Quality or Compliance discipline or other regulated industry, including a

minimum of 4 years of supervisory/management/leadership experience (direct or indirect).

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com