Director, Strategic Compliance and Quality Systems

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:

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 has responsibility to establish and maintain quality assurance programs to drive alignment of policies, processes and develop appropriate quality plan objectives to ensure the global Core Diagnostics division has a suitably effective Quality System that conforms to all established regulatory requirements and standards. This includes ensuring appropriate clarity of quality roles and responsibilities across Core Diagnostics manufacturing sites and Business Units, ensuring alignment, appropriate quality agreements and clear approaches to strategic compliance are understood and communicated as necessary across Core Diagnostics Global QA Functions as well as its various Business Units.

The incumbent is the designated Core Diagnostics Subject Matter Expert for Global Quality Systems, serving as an expert contact during internal and external inspections of the division establishment, and supporting similar inspections and audits across sites and business units within the division.

Leads all inspection readiness strategies and guides site compliance functional resources for Global Core Diagnostics. Provides guidance, best practices and communications to influence across sites and functions, ensuring QS metrics and monitoring are established and reported, as well as reviewing and determining when to react to potential quality trends. Interprets and recommends modifications to division and site policies and practices as needed, ensuring alignment to corporate quality policies. Balances inspection readiness activities with business priorities and quality plan objectives, while determining appropriate corrective actions and solutions to recommend to division, business unit and site leadership as appropriate. Makes decisions that translate programs from top management into operational plans and schedules; monitors and reports on progress and identifies goals to meet and maintain compliance certification status as necessary to support Core Diagnostics business strategies.
 

What You’ll Work On

• Interacts with senior management and external agencies/regulators concerning matters of quality compliance and quality system requirements for the Core Diagnostics division. Develops quality goals to support business strategies, aligned across functions in the organization, and ensures the quality plan objectives are carried out and reported on to key management.
• Provides overall leadership for Quality policies, approaches, and standard practices. Maintains alignment with US and International regulations and standards, as well as Abbott quality systems.
• Monitors and ensures compliance with FDA, ISO, IVDR regulations, and other regulations and standards as applicable; is responsible for internal audits for Global Core Diagnostics sites and businesses to ensure a robust program of oversight is in place, performed and reported on to key management.
• Responsible for leading multiple quality system elements and ensuring accessibility to tools, templates and training.
• Responsible for the success of quality and regulatory inspection preparedness through establishing and overseeing a