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 109,000 colleagues serve people in more than 160 countries.
Our location in Lake County, IL, currently has an opportunity for a Director IT Quality & Compliance. This role will guide and lead a Global function that ensures Quality, Compliance and Regulatory across the Abbott Enterprise for IT. This position will lead all teams across IT that will be accountable for software validation, quality assurance, quality engineering, and regulatory compliance process and operational improvements.
WHAT YOU'LL DO
Develops strategies working with Divisional IT and Quality as well as central IT and AQR. Drives standardization of processes, tools and compliance expectations across the enterprise. Keep abreast and others appraised of regulatory quality, compliance, and security issues affecting the IT arena through audit and risk analysis. Lead in the development and enforcement of policies and procedures to support a compliant and consistent IT environment across the Abbott enterprise. Provide technical consultation to Divisional and Corporate counterparts on leveraging and consolidating quality and compliance best practices solutions for competitive advantage. Assess, then train and educate the appropriate business and IT communities on regulatory, compliance and standardize best practice systems when appropriate. In conjunction with internal and external business and technology partners, lead in setting quality, compliance and regulatory strategy and vision to meet business objectives.
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Develops strategy, processes, governance, and team to support the following key processes for Application Development and Maintenance
Policy and Procedure Management
SLC Verification (SQA/VRB)
Non-Conformance / CAPA Management
Audit Preparation and Support
Service Provider Audits
Performance Review (MRM, etc...)
Infrastructure QA and Compliance
Works with cross functional executives in Division Quality, AQR, SOX and Internal Audit to align on strategy and ongoing maintenance of Abbott policies and procedures.
Establish quality assurance and quality system requirements for IT to meet Federal regulations that apply to computerized systems.
Develop and market software quality assurance and validation strategies to corporation and work with operating divisions and other corporate functions to execute consistent practices.
Initiate process improvements to reduce computerized systems development and validation cycle time and expense.
Provide expert consulting service in quality assurance activities that support computerized systems.
Understands global, regional and country specific requirements in order to support international compliance.
Establish and maintain quality assurance governance models for enterprise systems.
Manage department(s) that provides quality unit support for activities in IT ADM.
Budget, staffing, and resource management responsibilities.
Manage the integration of compliance initiatives into IT policy, i.e., document management, CAPA, systems quality assurance, training, supplier management, etc.
EDUCATION AND EXPERIENCE YOU'LL BRING
BS Computer Science, Engineering, Medical, Business, Quality or related field required.
10+ years of experience throughout the following environments:
Quality/Compliance management in a regulated healthcare environment
Overall management experience
Software Development and Validation
Regulated Software Development and Validation Industry Environments
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.
Internal Number: ABLAUS30992159ENUSEXTERNAL
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 109,000 colleagues serve people in more than 160 countries.