Manager, Biosafety

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.
• 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 is not a remote opportunity.
• Qualified candidates must currently live in the North Chicagoland area.
• Travel up to 10%.

What You’ll Work On

Responsible for ensuring divisional compliance with regulations and internal standards for Biosafety as well as serving as Biological Safety Officer for multiple divisions of Abbott. Act as the primary source of expertise for biosafety subject matter including compliance with international regulations and expectations including the US CDC, US USDA, the World Health Organization, and related agencies in other nations where we conduct business.  Responsible for establishing and maintaining Biosafety program with clear program elements, goals/priorities, strategy, and resources.

Compliance  

• Complies with all regulations and procedures in scope of the Biosafety programs.
• Ensures compliance with biosafety requirements through internal processes and implementation of strategies.
• Track company, industry, and regulatory activities to ensure effective biosafety compliance.
• Develops and provides training on the biosafety program elements, systems, or procedures.
• Assist Corporate in the development and implementation of biosafety technical standard.
• Develop long range plan to support biosafety strategy, considering long term goals and continuous improvement.
• Interface with regulators, agencies, and organizations to influence direction of regulations, requirements, and performance expectations.
• Represents Abbott with regulators during compliance inspections and permit applications.

Technical     

• Serves as the leading subject matter expert regarding the hazards/risks and control measures associated with biological materials and pathogens, including bacteria, virus, fungus and protozoan.
• Identify emerging regulations or new requirements impacting division products or biological materials used by division sites, communicate to the other division functions and ensure actions are put in place.
• Executes a biosafety program that includes corporate requirements and division specific requirements and is aligned with division priorities.
• Conducts product Biological Hazard Assessments to identify and minimize biological hazards to our customers.
• Develop and maintain formal biosafety systems and programs to ensure adequate oversight.  Partner with quality and operations to ensure biosafety requirements are incorporated into process design/development and manufacturing.
• Communicates across functions and disciplines and presents data to management.

Project Management 

• Manages multiple, often concurrent, projects and meets deadlines.
• Performs feasibility studies relat