Quality Program Manager - Production and Process Controls SME

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 115,000 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 family, be your true self and live a full life. You'll 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 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.
• A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Abbott Park, IL location within the AQR Abbott Quality Regulatory division.

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

The Quality Program Manager will support Divisions across all Abbott Quality Systems in activities associated with quality, regulatory compliance areas. The candidate will provide strategic, technical, and business support across all Quality Management Systems by interacting directly with Divisions and providing quality and technical expertise and strategic consulting activities for the Divisions.

The Quality Program Manager will also serve as a primary subject matter expert and owner of corporate policies in the areas of Production and Process Controls. The candidate must possess knowledge and experience of all quality management system requirements related to corporate policy and will serve as the expert on the knowledge of Production and Process Controls and how it interfaces with other areas of product quality subsystems and the Total Product Lifecycle development process. The SME must be able to interpret and apply world-wide regulatory and ISO requirements across multiple manufacturing sites and divisions globally (pharma, combination products, nutrition, and device)

The Quality Program Manager will also understand and apply global regulatory requirements (e.g., 21 CFR 820, ISO 13485) related to production and process controls, including Equipment Qualification and Process Validation, manufacturing operations and monitoring systems.

What You'll Work On:

• Assist all Abbott businesses (pharma, nutrition and device) with the planning, design, implementation, review and continuous improvement of manufacturing processes, including validation planning and strategy.

• Lead cross-functional initiatives to improve process capability, robustness, and compliance, using data-driven methods and risk management tools (e.g., FMEA, SPC).

• Review and provide recommendations on process and equipment qualifications, including:

• Process and equipment user requirement

• Equipment qualification (IQ/ OQ/PQ)

• Process Validation and Revalidation

• Cleaning validation

• Physical and Analytical Test Method Validation

• Maintain subject matter expertise by actively monitoring evolving regulatory expectations, industry trends, and emerging technologies, and translate these insights into corporate-level policies, processes, and guidance documents that are clear, actionable expectations for divisions.

• Deliver training on Abbott Quality Systems with emphasis on:

• Production and process controls

• Validation principles

• Applied Statistics for validation and process monitoring

• Equipment and manufacturing controls

• Provide expert level technical and consulting support to Abbott businesses in the areas of:

• Manufacturing process design and control

• Process validation and lifecycle management

• Equipment qualification and calibration

• Monitoring, trending, and statistical process control (SPC)

• Facilitate standardization and harmonization of production and process control programs across Abbott divisions including best practices for validation and monitoring.

• Possesses experience in regulated manufacturing industries such as: Medical Devices, Pharmaceuticals, Healthcare, Nutrition, Electronics/High Tech

• Travel - domestic and international - may range from 25 to 75%.

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

• Lead global committees and teams

• Provide direct business support

• Participation in industry groups

• Improve the effectiveness of the Abbott Quality Management System, including monitoring, trending, and analysis of Abbott's compliance performance

• Act as a change agent for incorporating best practice methods

• Liaison to Divisions on the Quality Management System

Position Accountability / Scope

• The scope of this position is Abbott-wide, covering all Abbott divisions / businesses.
• This position manages multiple global projects.
• Given the nature of the projects as they relate to regulatory compliance, the financial consequences for adverse regulatory findings or delayed product approval initiatives range from $10MM to $50MM.
• This position manages confidential information across the project lifecycle.
• Significant interaction with executive management with accountability for assigned projects.

Required Qualifications:

• 4-Year degree in Engineering, technical or scientific discipline.
• Managerial/Supervisory Experience - 4 years or greater preferred
• Engineering and/or Quality Assurance and/or Compliance and/or Manufacturing and/or Operations - 10 years of experience

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow 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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

The base pay for this position is $129,300.00 - $258,700.00. In specific locations, the pay range may vary from the range posted.