Abbott Sr. Manager, Quality System and Compliance in Irving, Texas
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 103,000 colleagues serve people in more than 160 countries.
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.
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
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.
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 email@example.com