Regional Manager, NA - Packaging Supplier QA

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.

     

JOB DESCRIPTION:

The Supplier Quality Assurance Regional Manager for Packaging must effectively develop, execute and manage the Quality Assurance Department in accordance with Corporate and Divisional policies and procedures in order to assure that proper controls are instituted and maintained.  The manager has overall responsibility to maintain high quality levels on all packaging commodities.  The manager must provide leadership for Global QA initiatives to implement quality systems/processes across Abbott Nutrition (AN) achieving quality improvements, cross plant consistency, and regulatory compliance.  The manager has final authority for product related decisions including acceptance, release, and post-production management of events or complaints.

Additional Main Responsibilities

• Effectively manage/develop the AN department staff to conduct packaging projects to ensure that all operational, quality & compliance aspects meet planned dates.
• Ensure department programs and quality system documents meet Corporate and Regulatory requirements to provide sufficient oversight to avoid regulatory vulnerability and regulatory action.
• Support plant, engineering operations and purchasing groups globally to ensure that commodities are capable and can be processed within manufacturing without events.
• Reviews performance of the department and personnel against approved objectives, budgets and plans, and takes necessary remedial actions.
• Insures that required records and documents, including qualification packages, supplier inspections,, vendor performance, product complaints, product disposition, and regulatory inspections are maintained.
• Manage the department operating model to support the program execution, performance monitoring and continuous improvement processes.
• Execute the qualification of suppliers and commodities to assure that Division programs and initiatives are met.
• Provide operational support to ANSC global operations by conducting event management.
• Utilize monitoring policies and procedures to assure that all products generated conform to predetermined Corporate/Division standards and specifications.  Anticipate supplier-related issues and proactively implement efficient, cost-effective solutions.
• Creates and implements development programs for the continuous improvement of vendors to achieve sustainable performance which meets AN requirements.

Accountability / Scope / Budget

• Under the guidance of the Director of Quality Assurance, this position is responsible for compliance with Corporate and Divisional QA policies, procedures, standards and specifications as well as regulations in applicable countries of operation.
• This position has budget responsibility.
• This position has an organizational setup with direct reports up to 4 exempts and 2 non-exempts, but direct oversight of a team of 15.

Additional Qualifications

• Education: Bachelor’s degree in physical or life science, engineering or business.  Masters degree preferred.
• Candidate must have demonstrated leadership skills/competencies with track record of success with no less than five years of direct supervisory management experience.
• Knowledge of applicable regulatory standards and GMP requirements used in manufacturing of conventional foods, infant formulas, medical foods, and foods for special medical purposes (FSMP)
• Expert knowledge of quality management systems and regulatory requirements. 
• This position requires excellent problem solving and decision making skills since the technology for many of Abbott's products are unique.
• This position requires a keen understanding of vendor relationship management and strategic sourcing. A thorough understanding of integrated processes and technologies involved in supply management is required. 
• The manager must have the ability to work and interact with many cultures in many time zones, and be capable of interpreting and analyzing technical data from different regions for decision making. The manager must have the ability to summarize and present technical recommendations and solutions to Abbott senior management 
• A minimum of 10 years of experience in Quality, Supply Chain and Manufacturing or related experience is required.  Experience working with International plants and affiliates is preferred.
• Travel is expected as part of the role, potentially around 10-20%.