JOB DESCRIPTION:The Opportunity Lead, manage, plan, and coordinate operational and administrative activities within the
IT Quality and Regulatory Assurance area to achieve compliance with regulations and industry standards, while minimizing impact on Global IT Organizations. This role is not within the software testing organization.
Accountable for global compliance to Abbott policies and procedures that have specific applicability in quality, including documentation and adherence to global regulations.
What You'll Work OnSoftware Life Cycle (SLC) Governance- Serve as a subject matter expert for the Abbott Software Life Cycle process.
- Provide quality oversight and guidance throughout system planning, development, validation, implementation, maintenance, and retirement activities.
- Ensure compliance with applicable regulatory requirements and internal quality standards.
- Support development and delivery of SLC training and awareness initiatives.
- Promote a culture of quality, compliance, accountability, and continuous improvement
- Identify opportunities to improve compliance processes, quality system effectiveness, and operational efficiency.
Quality Event Management / CAPA- Quality event identification, assessment, investigation, documentation, and resolution for suspected policy, process, procedure, or system nonconformities.
- Ensure effective root cause analysis, corrective and preventive actions (CAPA), and verification of effectiveness.
Quality System Documentation- Development, review, approval, and maintenance of policies, processes, procedures, standards, and work instructions in alignment with Abbott Quality System requirements and regulatory expectations.
Audit and Inspection Readiness- Support internal audits, external audits, supplier audits, and regulatory inspections.
- Maintain inspection readiness through effective quality system monitoring, audit response management, and remediation activities.
Quality Oversight and Business Partnership- Provide independent quality oversight, direction, and consultation to project teams, system owners, and business stakeholders.
- Ensure business objectives, risk management considerations, and quality requirements are appropriately balanced and aligned.
Risk Management and Compliance Decision Making- Utilize risk-based approaches to assess compliance impacts and support informed business decisions.
- Escalate significant compliance risks and recommend appropriate mitigation strategies.
Stakeholder, Relationship, and Escalation Management- Build effective partnerships across Quality, Regulatory, IT, and Business functions.
- Manage complex stakeholder relationships and provide leadership through issue resolution and escalation processes.
- Influence decision-making at multiple organizational levels to achieve compliant business outcomes.
Minimum Requirements & Qualifications:Minimum Qualifications:- Bachelor's degree or equivalent experience
- 8+ years combined experience in software development, validation, and/or regulated quality systems (QMS/GxP/CAPA).
- 1-3 years' experience in a regulated software development / validation environment (QMS)
- 1-3 years' experience in GxP quality systems for IT, Pharma, or Device.
- Strong experience in leading software validation efforts, providing software quality assurance support, providing quality system support to IT systems.
- Knowledge of regulations and standards that affect the health care industry.
Preferred Qualifications:- Effective communication skills and collaboration skills.
- Knowledge of Software Lifecycle and software methodologies (SLC processes).
- Knowledge of AI types and AI validation methods.
- Knowledge of SaaS validation and compliance
Supervisory Responsibilities - Has direct/indirect reports.
- Responsibility for performance monitoring and resource allocation.
- May have responsibility for setting goals, performance assessments and developing growth plan for direct reports.
Misc: This is an onsite role at Abbott location in
IL This is not a remote role/opportunity.
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.
- Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
The base pay for this position is $99,300.00 - $198,700.00
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 > Waukegan : J46
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 5 % 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)
