Commercial Quality Manager

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
Our molecular division delivers best-in-class innovative testing solutions for people around the world, providing answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions.

Position: Commercial Quality Manager
Location: AMD-Molecular Business Unit, Des Plaines, Illinois

Role Overview:

Our location in Des Plaines, Illinois is hiring for a Commercial Quality Director. This role will be responsible for ensuring that the region commercial affiliates implement and maintain cost effective quality system solutions and remain in compliance with regulatory requirements, fulfilling the commitments of the region/division or corporate compliance plans. Throughout establishing and maintaining quality assurance programs, policies, processes, procedures and controls regarding:

• Quality Management System,
• Training related to the Quality System and GMP
• Change Controls, Exceptions and CAPA
• Quality Events Handling, Complaints, Product Actions, Significant events & Counterfeiting, Tampering, Diversion and Product Theft
• Supplier Management
• Quality Audit Program
• Material Control
• Risk Management
• Quality Projects

What You’ll Work On:

• Provide Quality leadership in direct support of Invitro Diagnostic & medical device Distribution and Commercial Quality.
• Management and development of Quality Specialists, Engineers and Technicians.
• Manage the activities of the Post Market Surveillance Quality team.
• Responsible for managing Distribution and Commercial Quality operations across multiple countries and overseeing warehouse (WH) activities, managing secondary packaging and labeling activities.
• Support and encounter the internal and external audit processes and Health Authorities inspections.
• Support regional Supply Chain and Distribution in term of Good Distribution Practices (GDP) and Good Storage Practices (GSP) and Participate in Distribution projects, provide QA compliance.
• Support the Supplier QA programs, evaluation, performance monitoring, maintain Approved supplier list, Quality Technical Agreements, etc.
• Drive the Management Review process for Commercial Affiliates at the regional level.
• Promote sound, quality principles at Commercial Affiliates while minimizing cost increases and potential disruptions to business Act as Region technical resource regarding Quality Systems and compliance.
• Provide training to ensure compliance with identified quality goals and standards and overall technical and documentation support to commercial affiliates.
• Represent the Commercial Affiliates on Cross-Region/Divisional and/or Corporate teams.
• Approve or reject all affiliate quality related documents and records to assure that no errors have occurred or, if errors have occurred, that they have been appropriately investigated.
• Oversee the Nonconformance and Real-time data management portions of the Quality System and trending activities.
• Use risk management tools in different parts of the quality system to provide consistent and effective outcome.
• Support the Material Control system and assist the product disposition decision, product returns, product destructions.
• Support the complaint handling process and Field action.
• Provide Quality Assurance Body of Knowledge guidance and leadership to department and organization.
• Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Define and implement superior Process Control & Monitoring systems for KPIs and Metrics throughout the product distribution lifecycle.
• Provide influential peer leadership with international partner site to drive proactive quality improvements.
• Identify Quality Initiatives and lead cross-functional teams to complete them.
• Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organ.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Mianagement Systems (EMS), and other regulatory requirements.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications:

• Education: Bachelor's Degree in a related discipline.
• Experience:
  • 8-10 years of increasing responsibility, impact, and scope within a manufacturing support environment in quality.
  • 3-5 years in a supervisory or leadership role.
  • Experience with Class II or III medical devices.
  • Proven performance in nonconformance management and reduction, value improvement, risk reduction, and cost containment.
  • Ability to travel internationally to support manufacturing sites.
  • Demonstrated experience in process improvement methodologies (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, and Process Control & Monitoring (SPC).
  • Strong project management and people leadership skills.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong leadership skills, including goal setting and providing positive and constructive feedback to build relationships and improve business results.
  • Effective team collaboration in a fast-paced, changing environment.
  • Excellent verbal and written communication skills, with the ability to communicate effectively at multiple levels within the organization.

PREFERRED

• Master's Degree in related field
• Industry certification preferred.
• Six Sigma Black Belt strongly preferred.
• ASQ Certified Quality Engineer strongly preferred.

• Experience working in a broader enterprise/cross division business unit model preferred.
• Language Proficiency: Spanish

Apply Now

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Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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