Director Commercial Quality

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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 .
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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

Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.

This position works out of our Des Plaines, IL location (in office daily) in the Abbott Molecular Diagnostics, Quality Assurance Group.

The person hired in this role will lead the Commercial Quality Organization worldwide.

What You’ll Work On

• Strategy and Leadership: Set, prioritize, and execute the business strategy for the commercial QA organization. Partner with senior management to ensure results are delivered. Serve as the voice of quality on the Regional Commercial leadership team.
• Quality and Compliance: Establish, maintain, and improve quality and compliance in the commercial structure. Communicate the importance of an effective and compliant Quality System to employees and partners. Assess and report on Quality System effectiveness to management.
• Process Improvement: Develop, implement, and improve quality processes, procedures, automated systems, and reporting systems. Promote and oversee continuous improvement initiatives for worldwide commercial QA functions.
• Regulatory Compliance: Ensure compliance with all applicable internal, domestic, and international quality regulations, including EN ISO 13485, 21CFR 820, MDR/IVDR, JPAL, and CMDR. Interface with FDA/Regulators/Notified Bodies during audits.
• Team Management: Hire and retain a diverse, highly qualified staff. Provide ongoing performance feedback, set goals, and manage execution through coaching and mentoring. Maintain a safe and professional work environment.
• Training and Communication: Ensure adequate training programs for all requirements, including safety and business EHS goals. Develop and implement communication strategies for quality issues.
• Quality System Monitoring: Monitor and report the status of Commercial QA to upper management. Ensure policies and procedures are in place to meet applicable regulations and quality standards.
• Risk Management: Oversee the development and implementation of quality improvement plans using a risk-based approach. Anticipate changes in business and regulatory requirements and prepare contingency plans.
• Cross-Functional Collaboration: Direct complex global cross-functional process improvements. Interface with other disciplines, customers, internal clients, project staff, and external experts. Participate on teams to improve quality systems cross-divisionally and globally.
• CAPA Review Board: Actively participate on the CAPA Review Board, ensuring Exception Reports, investigations, and corrective actions are appropriate and compliant.

Required Qualifications

• Minimum bachelor’s degree in science, engineering or health-related discipline with 10 years’ industry or related experience and a minimum of 7 years’ experience in