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Senior Director, Quality Assurance

Company: Abbott Laboratories
Location: Lake Forest
Posted on: May 16, 2022

Job Description:

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 113,000 colleagues serve people in more than 160 countries.Our location in Lake Forest, Illinois currently has an opportunity for a Senior Director, Quality Assurance.Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support our customers' diagnostic testing and workplace service needs.WHAT YOU'LL DOThe position of Senior Director Quality Assurance is within our Toxicology business unit located at our U.S. headquarters in Lake Forest, IL. In this role you will lead the Quality function for the Toxicology business unit and help shape the future and create something special within the broader Abbott network.Core Job Responsibilities:

  • This role drives the development, implementation, improvement, and effectiveness of the Quality Management Systems (QMS) supporting Laboratory and Workplace Services (highly software driven) teams.
  • Acts as Head of Quality for the business unit, responsible for creating, planning and communicating overall strategic quality direction and initiatives for a diverse Toxicology business unit, including numerous laboratories, service operations, oversight of Third Party Manufacturers, and distribution entities.
  • Leads and manages the global quality organization across 6 laboratory and 3 workplace services sites.
  • Collaborates with global and site operations leaders to drive customer focus and continuous improvement.
  • Responsible for devising and maintaining an efficient Quality Management System (QMS) which reflects the vision, mission, and expectations of the Toxicology business unit, meets applicable regulatory and accrediting body requirements (specifically within Service and Laboratory industries), and aligns to Abbott Quality & Regulatory (AQR) policies for a services business.
  • Devise and execute Audit Readiness and Internal Auditing protocols that are in alignment with regulator expectations in the Workplace and Laboratory Services industries.
  • Implement service provider management programs for a diverse range of vendors, to ensure adherence to regulatory requirements, compliance with QMS and feasibility to execute on business requirements.
  • Utilize technical/professional knowledge and skills to establish, interpret, and appropriately execute company policies and applicable regulations and requirements.
  • Establish and manage governance and oversight mechanisms across the business unit to enable reporting of quality performance to business unit, Division and corporate leadership. This includes quarterly management review, monthly quality metric reporting, establishment of formal quality improvement plans and other effectiveness reporting as appropriate.
  • Ensure appropriate Toxicology representation on Division/Corporate quality programs and initiatives, assessing their applicability to Toxicology entities and leading and reporting on program implementation.
  • Provide decisions and recommendations to senior staff regarding quality related issues (e.g. laboratory testing quality issues, service operations quality issues, field actions and customer notifications, customer complaints, supplier issues, and regulatory compliance interpretation).
  • Demonstrates effective change leadership by building strategic partnerships across functional areas, business units, and geographies to further departmental and organizational objectives.
  • Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers.
  • Directs and controls the activities and budget for the BU QA function.
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of service or laboratory test issues that may occur and the quality system processes in place that manage these events.
  • Will develop and maintain key performance indicators to measure effectiveness of the Quality Management System. - Management Responsibilities:
    • Manages 30 staff globally located in multiple sites
    • Create vision, clear direction, and strategy for the team
    • Establish, manage and coach team with clear objectives and performance expectations
    • Attract, motivate, develop and retain highly skilled associates
    • Constantly monitor and improve team efficiency, effectiveness, and impact
    • Create an environment that values employees and encourages cooperation, open communication, and teamwork
    • Serve as a role model by demonstrating a commitment to client values, high performance standards, workplace diversity, and driving results -EDUCATION AND EXPERIENCE YOU'LL BRING
      • Bachelor's Degree in Life Sciences, Engineering, Quality or related field. Master's Degree or MBA preferred.
      • Minimum of 15 years of quality and operations related work experience in a Services or Laboratory organization with at least 5 years in a leadership role.
      • Have knowledge of cybersecurity / threat landscape, IT development processes / methodologies and Software as a Service industry that provides real-time services.
      • Proven success in:
        • Devising and installing a Quality Management System in a Services or Laboratory environment
        • Progressing department and site toward divisional and company goals
        • Monitoring all costs associated with assigned organizational unit
        • Monitoring industry trends and external environment in areas relevant to the assigned organizational unit
        • Implementing cross-site processes that meet diverse regulatory requirements including, ISO 17025, HIPAA, SOC2, FedRAMP, IEC 62304, CLIA, CAP, and SAMHSA, as well as regulated drug testing requirements for FMCSA, FAA, and FRA
        • Being a subject matter expert and able to lead a team of technical experts in Software development, CAPA, QMS, SOP development, Validation, Complaint Management
        • Developing and/or identifying new work processes that will have broad applicability throughout the company
        • Conducting root cause analysis on highly technical problems and solving problems that impact work processes and personnel in multiple units or departments 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 communitiesLearn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com 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

Keywords: Abbott Laboratories, Lake Forest , Senior Director, Quality Assurance, Executive , Lake Forest, California

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