IT Quality & Regulatory Assurance 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 115000 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 your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity working mothers female executives and scientists.

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.

Accountable for global compliance to Abbott policies and procedures that have specific applicability in quality including documentation and adherence to global regulations.

What Youll Work On

• Serves as a source of information to IT organizations on the compliance needs and regulatory environment.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Responsible for the interpretation and communication of systems compliance regulations.
• Responsible for the analysis development and implementation of metrics for assessing quality software processes and systems.
• Provides leadership to maintain compliance and consistency.
• Understands organizations vision goals and strategies.
• Stimulates creativity and innovation in others.
• Manage associated budget responsibilities including meeting expenses recovery and forecast plans; continually looking for opportunities for cost avoidance and cost reductions.
• Represents Software Quality Assurance on cross divisional process improvement initiatives.
• Ensures appropriate consistent and good communications at all management levels.
• Participates in setting policies and procedures.
• Establishes and maintains productive relationships with all levels in Abbott IT organization and with external partners.
• Aligns with and influences our external partners in support of divisional and corporate IT strategies.
• Operates within broad goals and objectives.
• Makes strategic decisions that impact division/sites and/or influence global organizations.
• Responsible for implementing and maintaining the effectiveness of compliance at a division level.
• Actively addresses employee issues in a constructive and timely manner.
• Responsible for team morale and promotes cohesive attitude.
• Responsible for conformance and adherence of policy process and procedure documentation in accordance with Abbotts quality system.
  

Minimum Requirements & Qualifications:

Minimum Qualifications:

• Bachelors degree or equivalent experience
• 8 years combined experience in software development validation and/or regulated quality systems (QMS).
• 1-3 years experience in a regulated software development / validation environment.
• 1-3 years experience in leading software validation efforts providing software quality assurance support providing quality system support to IT systems.
• 1-3 years experience in GxP quality systems for IT Pharma or Device.
• 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.
• 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.

• Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
• 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 on Facebook at and on Twitter @AbbottNews.

The base pay for this position is

$113300.00 $226700.00

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

Information Risk & Quality Assurance

BTS Business Technology Services

United States > Waukegan : J46

Standard

Yes 5 % of the Time

Not Applicable

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: EEO is the Law link - Espanol: Experience:

Manager