Senior Compliance and Quality Controls Specialist

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 position works out of our Lake Forest, Illinois site or Willis Tower location in the Rapid and Molecular Diagnostics IT division.

What You’ll Work On

• Acts as the subject matter expert for the IT organization for all integrated controls as well as quality and compliance related activities.

• Evaluates scope of planned testing activities for assigned audits and align with integrated controls framework

• Drives IT audit, quality and compliance readiness and monitoring activities against the IT integrated controls framework

• Manage all phases of quality and non-quality audits of IT systems audits from audit readiness to observation evaluation, to follow-up and remediation in cooperation with the responsible Business Relationship Managers and their teams

• Assists the IT organization by assessing their compliance level for all key processes and in the development and implementation of associated remediation plans

• Establishes and maintains productive relationships with all audit, compliance and IT stakeholders including external partners

• Champion change, innovation, and process thinking; open to new ideas for global solutions

• Identifies and executes on need for update and/or improvement to the integrated controls framework based on monitoring trends and/or control environment changes

Risk Evaluation and Remediation

• Evaluates and prioritizes remediation activities and execute risk acceptance process where appropriate

• Practices appropriate risk-based root cause analysis methodology that considers the organization’s strategic direction and priorities

• Drives IT compliance risk remediation and process improvement for the assigned region/domain

• Works with IT to deploy new compliance processes, solutions, and controls to address remediation priorities

• Represents Compliance on process improvement and remediation initiatives

• Champion change, innovation, and process thinking; open to new ideas for global solutions

Compliance and Communication

• Acts as a liaison for the IT organization for all controls and compliance related monitoring activities

• Communicates effectively with all levels of the organization.

• Ensures adherence to relevant regulatory, corporate, and quality standards.

• Maintains robust cybersecurity, privacy, and security protocols.

• Supports all RDx IT internal and external audits throughout the year

• Maintain system protocols by implementation policies and procedures in accordance with Quality Management System (QMS) policies

• Uses a qualitative and quantitative metrics-driven approach to drive IT compliance priorities

Required Qualifications

• B.S. in Information Technology, business administration or another discipline relevant for the IT healthcare industry or equivalent experience.
• 5+ years of IT or business experience in large or midsized multinational organization.
• Broad IT or business expertise in various disciplines like audit, quality and compliance, systems development and support.
• Direct experience leading governance boards of large multi-disciplinary projects.
• Experience leading teams - indirect staff and indirect project teams.

Minimum Education & Qualifications

• Major in Business, or related field.
• Bachelor’s degree or equivalent experience.
• Ability to explain and present complex technical ideas to both technical and non-technical audiences.
• Have IT compliance background, be a self-directed individual with good project management and good written and verbal communication skills; be comfortable working with managerial and technical professionals worldwide. 

Preferred Qualifications

• Knowledge of Sarbanes Oxley (SOX) IT general controls, IT security familiarity with Industry System Quality Standards CobIT, ITIL, TickIT and FDA Guidelines on Software Validation.

• Expertise in a regulated industry and frameworks and process assessment methods, such as ISO, IEEE.

• Experience with data privacy, data protection, cybersecurity and secure lifecycle (SLP).

• Experience with quality management system processes including Training, Nonconformance, Validation and Vendor management.  

• Strong interdisciplinary, and excellent intercultural influence, and networking skills.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is

$111,300.00 – $222,700.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

IT Business Relationship Management

     

DIVISION:

BTS Business Technology Services

        

LOCATION:

United States > Lake Forest : J55

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf