Director, Quality Systems and Compliance

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.

·         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 Diabetes Care (ADC) is looking for a Director of Quality Systems and Compliance. This person will provide strategic and tactical direction for Global Compliance programs. The Director will establish, maintain and improve quality system programs, policies, procedures, compliance and best practices across division manufacturing sites, Mergers and Acquisitions, or other programs established within the Program Management office.

The Director will advise the DVP of QA and other senior staff on critical matters such as compliance risks within the division's manufacturing plants, TPMs, suppliers nonconformance evaluations and other potential emerging issues, and maintain a strategic focus on changing global regulations so the business is proactive to address any potentially challenging laws or requirements. This person will interact with regulators, government agencies, and participate with global organizations associated with the industry to allow for external personnel become more aware of the business and the expertise within the organization. The Director is responsible for ensuring quality systems and/or programs for distribution centers, pilot plants, research facilities, and contracted sites meet Abbott quality standards.

What You'll Work On

• Minimize the probability of Quality compliance issues by providing feedback to all aspects of the quality, operations, Purchasing, R&D, regulatory and other functions division wide, through effective interface with division personnel.

• Build positive relationships globally with federal, state, local regulatory agencies, and law enforcement officials to further strengthen Abbott's reputation as a pro-active cooperative company dedicated to delivering superior quality products.

• Develop strategies to minimize, reduce, or otherwise eliminate potential adverse publicity, business interruption, corporate liability, loss of consumer confidence, and / or lost sales.

• Provides direction, support, leadership and management of compliance to Global Regulations, Standards, Directives, and Provisions to maintain a competitive advantage. Works with corporate, other divisions and cross functional teams to establish governance to assure policy, procedures and pro