Senior IT Quality Audit Manager

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.

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 Senior IT Quality Audit Manager will work out of one of our two offices in the office of either site in IL or St. Paul in MN locations.

The Senior IT Quality Audit Manager will lead, manage, and coordinate IT Quality Audit activities to achieve compliance with regulations and industry standards, while minimizing impact on Global IT Organizations. The IT Internal Sr Quality Audit Manager is accountable for ensuring compliance, identifying risks, and evaluating the effectiveness of internal controls within Abbott. The role is responsible to assess the organization's operational, and regulatory processes, providing unbiased and objective evaluations. This position is key to safeguarding Abbott's assets, improving operational efficiency, and supporting Abbott's compliance commitment to applicable laws and regulation, in the US and countries where Abbott may do business. The role's evaluation responsibility includes Supplier Quality Evaluation to ensure suppliers meet quality standards and requirements for Abbott - evaluating and managing the quality performance of suppliers, developing supplier quality programs, and driving continuous improvement initiatives.

What You'll Work On

Responsible for internal quality audit activities as required by Corporate and Divisional Policies and procedures. Manage the internal quality audit team and associated budget responsibilities.

Organizational responsibilities and expertise in the following areas:

Core Job Responsibilities:

Internal Quality audit:

• Conduct Internal Audits: Perform comprehensive and risk-based internal audits of operational and compliance processes within Abbott. Assess the adequacy and effectiveness of internal controls, identify control deficiencies, and provide practical recommendations for improvement.

• Risk Assessment: Identify potential risks and vulnerabilities within Abbott's processes and systems. Develop and execute audit plans to address identified risks and ensure compliance with relevant regulations and industry standards.

• Compliance Monitoring: Review and assess compliance with applicable laws, regulations, and industry guidelines, such as HIPAA, HITECH, and other healthcare-related regulations. Stay updated on changes in regulations and assess their impact on internal controls and operations.

• Audit Documentation: Prepare clear, concise, and well-organized audit work papers, reports, and other documentation. Ensure proper documentation of all audit findings, recommendations, and actions and communication to management.

• Process Improvement: Collaborate with stakeholders to identify opportunities for process improvements and operational efficiencies. Provide recommendations for enhancing controls, streamlining processes, and mitigating risks.

• Audit Follow-Up: Monitor and track the implementation of audit recommendations and management action plans. Verify the effectiveness of remedial actions taken to address identified deficiencies.

• Stakeholder Engagement: Build strong relationships and collaborate with cross-functional teams, including finance, operations, compliance, and legal departments. Communicate audit findings, recommendations, and best practices to stakeholders, including senior management.

Supplier Quality

• Supplier Evaluation: Develop and implement a comprehensive supplier evaluation process to assess suppliers' quality management systems, capabilities, and performance. Conduct audits and assessments to evaluate supplier compliance with quality standards, specifications, and applicable regulations.

• Quality Program Development: Establish and maintain robust supplier quality programs, including supplier qualification, performance monitoring, and ongoing evaluation processes. Define quality metrics, key performance indicators (KPIs), and scorecards to track and communicate supplier performance.

• Risk Assessment: Identify and assess potential risks associated with suppliers, including quality, compliance, and delivery risks. Collaborate with cross-functional teams to develop risk mitigation strategies and contingency plans to ensure continuity of supply.

• Performance Improvement: Collaborate with suppliers to drive continuous improvement initiatives. Provide guidance and support in implementing corrective and preventive actions (CAPAs) to address quality issues and enhance supplier performance. Monitor the effectiveness of improvement initiatives and ensure sustained improvement over time.

• Supplier Communication: Establish effective communication channels with suppliers to convey quality expectations, requirements, and performance feedback. Conduct regular meetings and performance reviews with suppliers to discuss quality-related matters, address concerns, and foster collaborative relationships.

• Data Analysis and Reporting: Analyze supplier quality data, performance metrics, and trends to identify areas for improvement and provide actionable insights. Prepare and present regular reports and dashboards to management, highlighting supplier performance, trends, and improvement opportunities.

• Compliance and Regulatory Support: Ensure supplier compliance with relevant quality standards, regulations, and industry requirements. Stay updated on evolving regulatory requirements and communicate changes and expectations to suppliers.

Required Skills and Education:

• 7+ years required in supplier Quality management, supplier evaluation, or supplier development roles. Familiarity with quality management systems (e.g., ISO 9001) and supplier quality tools and methodologies (e.g., APQP, PPAP, SPC).

• Proven experience in internal auditing, preferably within the healthcare industry. Familiarity with healthcare regulations, such as HIPAA, is highly desirable.

• Strong understanding of internal control concepts, risk assessment methodologies, and audit techniques.

• Strong understanding of quality assurance principles, supplier quality management practices, and industry standards.

• Knowledge of regulatory requirements and quality standards relevant to the industry or products.

• Proficiency in using quality management software, audit software tools, data analysis tools, and Microsoft Office applications.

• Bachelor's degree in engineering, quality management, supply chain management, or a related field.

Position Accountability/Scope:

• Complexity of deliverables: Manages Projects and deliverables at the division or cross-division level.

• Direct Budgetary Responsibility and Cost of Engaged Resources (Does not imply signature responsibility): 0-$5MM.

• Travel: 10-20%

Preferred Skills:

• A professional certification such as Certified Internal Auditor (CIA) or Certified Healthcare Auditor (CHA) is preferred.

• A relevant professional certification, such as Certified Quality Manager (CQM) or Certified Supplier Quality Professional (CSQP), is preferred.

• Analytical mindset with the ability to analyze data, identify trends, and develop actionable insights.

• Excellent communication and negotiation skills to effectively collaborate with suppliers and internal stakeholders.

• Project management skills to drive initiatives, manage priorities, and meet deadlines.

• Analytical mindset with the ability to identify risks, evaluate controls, and provide practical recommendations for improvement.

• Excellent communication skills, both written and verbal, to effectively communicate complex concepts and audit findings to diverse stakeholders.

• Strong mindfulness, organizational skills, and ability to prioritize and manage multiple tasks effectively.

Supervisory/Management Responsibilities:

• Up to 5 direct/indirect reports

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 $125,300.00 - $250,700.00. In specific locations, the pay range may vary from the range posted.