1+ months
2018-03-152018-05-13

Sr. Manager - Compliance

Abbott
Des Plaines, IL

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.

Abbott Molecular has an opening for Sr. Manager - Compliance. This Manager is responsible for leading internal and external audit strategy to ensure audit readiness.  Manages a team of auditors and acts as a change leader, responsible for management of improvement activities to improve quality systems, audit readiness, and compliance across the division.
Leads the audit community of practice for the division and participates in corporate teams as an SME.

Core responsibilities include:
•Acts as Subject Matter Expert for Audit in Inspections and External Audits

•Directs audit management, staffing, and logistics and allocates roles and responsibilities prior, during and post audit. Reviews and approves audits performed by direct reports and auditing team

•Responsible for reporting Audit Outcomes and Division owner of the QA Audit Systems.

•Directs the division readiness program, including risk prioritization & mitigation.

•Evaluates published Regulatory Agency (e.g. FDA) guidance, changes to external standards, actions and audit findings to assess impact and take action to mitigate risk to the business.

•Evaluate trends from available sources to provide perspectives on recent audit findings in related industries or Abbott as a whole.  From this trending provide a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.

  • Leads briefings and technical meetings for internal and external representatives.
  • Interacts frequently with internal and external management and senior-level representatives concerning projects, operational decisions, scheduling requirements and or contractual clarifications.
  • May liaise with customers and suppliers.
  • Responsible for managing multiple quality system elements/functions as defined in the site Quality Manual.
  • Implements the quality plan in accordance with the quality objectives/goals and maintains the effectiveness of the quality system.
  • Determines staffing and other resource requirements needed to achieve business goals and compliance requirements.
  • Resolves project team issues.
  • Leads complex process improvement teams and/or initiatives.
  • Responsible for the development and management of staff.
  • Responsible for ensuring that functional areas of responsibility have adequate training programs for adhering to all safety requirements and business EHS goals.
  • Develop quality goals based on the business strategies, collaborates with other business units on common goals and drives for results.
  • Additional responsibilities may include: Establish and implement necessary communication strategy for the improvement and awareness of the quality issues.
  • Responsible for department financials and for managing cost improvements.
  • Responsible for global QA function within one discipline or multiple disciplines at one site.
  • Balance complex resource needs across QA functions.
  • Decision making that has an extended impact on work processes and outcomes, that could cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity.

    Education and experience requirements:

    4 year degree in a scientific or technical discipline or equivalent experience (minimum 5 years in area of discipline). Minumum 7-10 years of experience in function or related field. Masters & above degree preferred. 4-6 years of direct supervisor experience.   Must have demonstrated solid knowledge and experience in discipline. Leadership experience is required. Considered a Subject Matter Expert and key contributor to initiatives. Leader and key contributor to initiatives and advancement of the Quality organization. Emerging Leader. Demonstrates strong leadership competencies. Makes decisions and charts course through careful evaluation of risks and benefits with limited information in conjunction with Director. Builds/drives relationships and teamwork within team and across functions with professional demeanor.


    Job Family: Operations Quality
    Division: AMD Molecular
    Travel: Yes, 10 % of the Time
    Medical Surveillance: No
    Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Sr. Manager - Compliance

Abbott
Des Plaines, IL

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Sr. Manager - Compliance

Abbott
Des Plaines, IL
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