Manager AQR Quality Program

Job description

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.

JOB DESCRIPTION:

The function of the Quality Program Manager is to provide leadership, oversight, and project management covering Abbott's Quality System. This includes division / business support and quality expertise and consulting activities.

MAIN RESPONSIBILITIES

• Provide leadership and direction for furthering the development of the Abbott-wide Inspection Readiness Program.
• Act as a strategic partner for ensuring that our business locations are effective in the full life cycle of a third party inspection (preparation, execution, and response).
• Provide direction and consultation for third-party inspections including the identification and review of outstanding issues, facilitating inspections, liaison training, and promoting effective and professional inspection facilitation.
• Capable of assessing, and providing meaningful feedback regarding compliance status, effectiveness of management teams, and related quality and operational systems.
• Provide scheduling and detailed project tasks for assigned sub-teams to ensure milestones are implemented.
• Review and support creative solutions to key topics and utilize risk management principles.
• Build and maintain a strategic focus on emerging regulations and their potential impact on Abbott is essential to success in this role.

Serve as a Technical Advisor, Consultant, or Subject Matter Expert including:

• Technical consultant to business
• Represent Abbott both internally and externally in key areas
• Recognized expert (and sought after) both internally and externally

In addition, the following technical skills are preferred:

• Significant interaction with executive management with accountability for assigned projects.
• Candidates must have a fundamental understanding of regulatory inspections and quality systems.
• Proven technical project leader with an emphasis in Inspection Management and Regulations

QUALIFICATIONS

Education Requirements:

Bachelors Degree (± 16 years)

4-year degree in a technical or scientific discipline

Experience/Background:

Minimum 10 years

Managerial/Supervisory Experience - 4 years

Quality Assurance and/or Compliance and/or Analytical Laboratories and/or Manufacturing and/or Operations - 10 years

Project Management - 3 years

Total combined minimum years of experience required: 10-12 (Not necessarily the sum of the above)

Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.

JOB FAMILY:

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