Senior Compliance and Quality Controls Specialist

Posted:
8/29/2024, 1:46:01 AM

Location(s):
Lake Forest, Illinois, United States ⋅ Chicago, Illinois, United States ⋅ Illinois, United States

Experience Level(s):
Senior

Field(s):
Legal & 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:

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

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

As a Senior Compliance and Quality Controls Specialist, you will support IT Audits, Quality and Compliance operations, providing leadership and direction to IT personnel ensuring Rapid Diagnostics (RDx) IT organizational compliance, audit readiness and timely audit finding remediation. In this position, you will drive IT audit and compliance readiness and monitoring activities that are aligned to an IT integrated controls framework. This position is responsible for implementing changes across the organization driven by global policy and the controls framework. This is a hands-on role, which will suit a self-starter.

What You’ll Work On:

Compliance and Audit Support

  • 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 the 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 remediations in alignment with responsible Business Relationship Managers and their teams.
  • Assists the IT organization by assessing their compliance level for all key processes within the development and implementation phases of associated remediation plans.
  • Establishes and maintains productive relationships with all Audits, compliance, and IT stakeholders including external partners.
  • Champion change, innovation, and critical 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.

Compliance and Communication

  • Engages directly with IT senior leadership in meetings and providing status reports.  
  • 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.
  • Supports all RDx IT internal and external audits throughout the year.
  • Uses a qualitative and quantitative metrics-driven approach to drive IT compliance priorities.

Minimum Education & Qualifications:

Required Qualifications

  • B.S. in Information Technology, Cybersecurity, business administration or another discipline relevant for the IT healthcare industry or equivalent experience
  • 7+ years of IT or business experience in large or midsized multinational (global) 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.
  • IT compliance background that is a self-directed individual with good project management and good written and verbal communication skills. Must be comfortable working with managerial and technical professionals worldwide.
  • Experience managing all phases of Quality and non-Quality audits including pre-audit, in-audit, and post-audit activities.
  • Strong experience in a regulated industry and integrated controls frameworks and process assessment methods, such as ISO, IEEE.
  • Experience supporting IT audit, quality and compliance operations and provides leadership direction to the remediation and readiness personnel on IT controls and compliance.

Preferred Qualifications

  • Knowledge of Sarbanes Oxley (SOX) IT general controls, IT security familiarity with Industry System Quality Standards such as CobIT and ITIL
  • Experience with data privacy, data protection, cybersecurity, and software lifecycle.
  • Experience with quality management system processes including Training, Nonconformance, Validation and Vendor management.
  • Strong negotiation skills ensuring the company’s policies and procedures are adhered to.
  • Strong interdisciplinary, and excellent intercultural influence, and networking skills.
  • Experience leading teams - indirect staff and indirect project teams.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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

$95,000.00 – $190,000.00

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

     

JOB FAMILY:

Information Risk & Quality Assurance

     

DIVISION:

BTS Business Technology Services

        

LOCATION:

United States > Lake Forest : J55

     

ADDITIONAL LOCATIONS:

United States > Chicago : Willis Tower Building 233 S Wacker Dr.

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

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

Abbott

Website: https://abbott.com/

Headquarter Location: Illinois City, Illinois, United States

Employee Count: 1001-5000

Year Founded: 1944

IPO Status: Public

Last Funding Type: Post-IPO Debt

Industries: Biotechnology ⋅ Emergency Medicine ⋅ Genetics ⋅ Health Care ⋅ Health Diagnostics ⋅ Manufacturing ⋅ Medical ⋅ Medical Device ⋅ Nutrition ⋅ Pharmaceutical