At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

THIS POSITION CAN BE BASED OUT OF SYLMAR, CA, ST. PAUL, MN OR PLYMOUTH, MN

Position Summary

Directs, manages, plans and administers the operational and administrative activities of the IT Compliance staff in the Medical Device division. Develops staff through mentoring, coaching, training and motivation. Manages a staff responsible for all phases IT compliance. Leads IT compliance process improvement and cost efficiencies for division and is proactive on cross divisional and/or global initiatives.

Main Responsibilities

Responsible for the interpretation and communication of systems compliance regulations. Cross business unit IT responsibilities in support of Application Development and Support activities performed by BTS (corporate Business Technology Services/IT) and information technology work and activities performed by Division IT or engineering groups, Labs or any other division-retained information technology activities governed by divisional policies and procedures.

In support of Abbott’s IT organization:

Represent IT, answer and/or coordinate answers and remediation activities due to findings for:

• Internal Quality Audits of IT (Abbott Quality Reviews (AQR) & Division Quality)
• Corporate Internal Audits
• External Inspections

  Audit support topics include Validation, Qualification, Supplier QA, Data Integrity, Security

  In support of Division IT:

  Procedures, Document Management and Training Requirements:

  • Determine what Policies Division IT is going to follow
  • Own and manage Division IT procedures
  • Define IT training needs by ensuring training is in place and applied to right people
  • Coordinate with BTS Doc center for division impacting BTS procedure updates/revisions

    CAPA:

    • Work with BTS in support of IT CAPAs under BTS process
    • Divisional IT Analyst to own and manage Division CAPA’s for local division resource or process caused IT non-conformances and audit findings
    • Help represent division at BTS Change Advisory Board (CAB)

      Quality Metrics:

      • Understand division impacting IT metrics performance reported at BTS Management Review Meetings (MRM)

        Represent metrics performance in division MRM and/or other forums

        • Take BTS MRM metrics as given and report in Div. MRM
        • High familiarity with BTS Quality Agreement
        • Hold BTS accountable to BTS & Division Quality Agreement (as an internal supplier if required)

          Validation:

          • Lead SQA for local projects or coordinate like business resources
          • Owns validation process and deliverables
          • Defends validation during inspections
          • Provides SLC/SQA expertise to division including Data Integrity
          • May also have a role with Product Software validation

            Other general responsibilities:

            Understands corporation's vision, goals and strategies.

            Aligns department priorities appropriately, determines critical success factors, evaluates and pursues initiatives, investments and opportunities based on fit with strategies.

            Champion change and innovation.

            Stimulates creativity and innovation in others.

            Open to new ideas.

            Supports those who initiate change and take risks.

            Promotes a global perspective.

            Responsible for setting goals, performance assessments and developing growth plan of IT Compliance employees.

            Responsible for implementing and maintaining the effectiveness of compliance system at a global level.

            Confronts and deals with employee’s issues in a constructive and timely manner.

            Responsible for the overall morale of the team and promotes cohesive attitude.

            Manages IT compliance staff in the analysis, development and implementation of metrics for assessing quality software processes and systems.

            Implements process improvements as a result of metrics analysis.

            Represents division on cross divisional process improvement initiatives.

            Accountability

            Oversee and control department budgets, project capital/RCE expenditures and ROI; develops, monitors and meets expense, recovery and forecast plans; continually looks for opportunities for cost avoidance and cost reductions.

            Ensures good communications at all management levels globally regarding IT compliance practices.

            Responsible for compliance with applicable Corporate and Divisional policies and procedures.

            Participates in setting policies and procedures.

            Establishes and maintains productive relationships with all levels in Abbott IT organization and with external partners.

            Acts as a liaison and regulatory compliance expert to IT organizations to assure successful implementation.

            Serves as a source of information to IT organizations on the compliance needs and regulatory environment.

            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 or global organizations.

            Qualifications

            Bachelor’s Degree or equivalent experience, preferably in Computer Science or Information Systems.  

            10-15 years’ experience in quality systems analysis, or equivalent combination of education and work experience.

            3-5 years’ supervisory experience,

            2-3 years strategic IT planning experience,

            Experience with Quality System Regulations, GxP, and system validation processes, required.

            Ability to explain and present complex technical ideas to both technical and non-technical audiences at all levels up to the highest in a persuasive and convincing manner;

            Broad and deep IT knowledge coupled with equivalent knowledge of the processes and activities of the business.

            OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL
            Job Family: IT Services & Solutions Delivery
            Division: GIS Global Information Services
            Additional Location: United States - Minnesota - Plymouth
            Travel: Yes, 10 % of the Time
            Medical Surveillance: Yes
            Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)