Global Quality Director for Commercial Operations

4 weeks ago

Des Plaines, Illinois, United States Abbott Full time

About the Role:

Abbott is a global healthcare leader that is committed to improving people's lives. We are looking for a highly experienced and skilled Global Quality Director for Commercial Operations to lead our commercial quality organization worldwide.

About Abbott:

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 114,000 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 family, be your true self and live a full life. You'll also have access to:

  • Career development with an international company where you can grow the career you dream of .
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
  • A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity:

Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level. This position works out of our Des Plaines, IL location (in office daily) in the Abbott Molecular Diagnostics, Quality Assurance Group.

What You'll Work On:

  • Strategy and Leadership: Set, prioritize, and execute the business strategy for the commercial QA organization. Partner with senior management to ensure results are delivered. Serve as the voice of quality on the Regional Commercial leadership team.
  • Quality and Compliance: Establish, maintain, and improve quality and compliance in the commercial structure. Communicate the importance of an effective and compliant Quality System to employees and partners. Assess and report on Quality System effectiveness to management.
  • Process Improvement: Develop, implement, and improve quality processes, procedures, automated systems, and reporting systems. Promote and oversee continuous improvement initiatives for worldwide commercial QA functions.
  • Regulatory Compliance: Ensure compliance with all applicable internal, domestic, and international quality regulations, including EN ISO 13485, 21CFR 820, MDR/IVDR, JPAL, and CMDR. Interface with FDA/Regulators/Notified Bodies during audits.
  • Team Management: Hire and retain a diverse, highly qualified staff. Provide ongoing performance feedback, set goals, and manage execution through coaching and mentoring. Maintain a safe and professional work environment.
  • Training and Communication: Ensure adequate training programs for all requirements, including safety and business EHS goals. Develop and implement communication strategies for quality issues.
  • Quality System Monitoring: Monitor and report the status of Commercial QA to upper management. Ensure policies and procedures are in place to meet applicable regulations and quality standards.
  • Risk Management: Oversee the development and implementation of quality improvement plans using a risk-based approach. Anticipate changes in business and regulatory requirements and prepare contingency plans.
  • Cross-Functional Collaboration: Direct complex global cross-functional process improvements. Interface with other disciplines, customers, internal clients, project staff, and external experts. Participate on teams to improve quality systems cross-divisionally and globally.
  • CAPA Review Board: Actively participate on the CAPA Review Board, ensuring Exception Reports, investigations, and corrective actions are appropriate and compliant.

Required Qualifications:

  • Minimum bachelor's degree in science, engineering or health-related discipline with 10 years' industry or related experience and a minimum of 7 years' experience in a medical device/Pharmaceutical or IVD quality environment.
  • Minimum 5 years prior management experience.
  • Demonstrated ability to understand/familiarity with applicable FDA and Worldwide regulations, and other relevant clinical/regulatory requirements. IVDR and/or Class III or II medical device background in a Quality Leadership role. Quality System Regulations knowledge (ISO 9001, ISO 13485).
  • Demonstrated ability to create relationships, influence and move critical projects forward in alignment with key stakeholders.
  • Strong interpersonal skills. Strong leadership skills with demonstrated ability to create momentum and deliver excellent results highly desired.
  • Demonstrated ability to influence change upwardly and laterally across the business.
  • Ability to merge business and compliance needs to achieve effective solutions.
  • Experience working in a broader enterprise/cross division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment.
  • Experience of managing multiple countries/markets with diverse environment.
  • Experience in conducting and handling audits and inspections.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Ability to travel, including internationally.

Salary: The estimated salary for this position is $143,300.00 - $286,700.00 per year, depending on location and experience.

Job Family: Operations Quality

Division: AMD Molecular

Location: United States > Des Plaines : DP01

Work Shift: Standard

Travel: Yes, 20 % of the Time

Medical Surveillance: Not Applicable

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

About Abbott: Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

Disclaimer: EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

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