Lead Logistics & Distribution Quality Specialist

Abbott Laboratories; Madison (WI); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott Laboratories is seeking a Logistics & Distribution Quality Leader to direct quality compliance across international and domestic product movements, warehouse operations, and materials management. You will shape and maintain a comprehensive quality program aligned with the enterprise QMS, ensure audit readiness, and represent Supply Chain, Logistics, and Warehouse in audits.

You will oversee change control, develop SOPs, support ISO/FDA audits, and lead risk assessments while partnering

Qualifications

• Bachelor’s degree or GED with relevant experience as described in duties.
• 7+ years of proven experience in operations quality control/assurance.
• 5+ years of experience with warehouse management/ERP systems.
• 3+ years of experience with Quality Management Systems (GMP/CAP/ISO13485).
• Proficiency with MS Office, especially Excel.

Responsibilities

• Oversee change control processes across Logistics & Distribution.
• Create and audit warehouse SOPs, WI’s, forms and job aids.
• Represent Warehouse in ISO and FDA audits as SME.
• Lead IPs and measure operational impact; drive improvements.
• Maintain compliance by training and auditing policies and processes.
• Monitor performance metrics and drive continuous improvements.
• Collaborate with Quality and Supply Chain teams to ensure compliance.
• Lead supplier quality, audit programs, investigations, and risk assessments.
• Support ERP expansion and Logistics quality initiatives.
• Provide enterprise-wide training on quality processes.

Skills

Quality control

MS Excel

Analytical/problem solving

Communication skills

Education

Bachelor’s degree in Logistics/Supply Chain/Industrial Engineering

GED with 4 years relevant experience

Tools

Oracle

SAP

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 122,000 colleagues serve people in more than 160 countries.

The Opportunity

The Logistics & Distribution Quality Leader will lead and direct efforts as it relates to quality compliance and controls across international and domestic product movements, warehouse operations and materials management. They will be responsible for identifying, developing, implementing, and maintaining an all-encompassing quality compliance program that aligns with our enterprise QMS and ensures our facilities and processes are audit ready. They will be responsible for representing Supply Chain, Logistics, and Warehouse in all internal and external Quality Audits.

What You’ll Work On

Include, but are not limited to, the following:

• Oversee the Change Control processes, coordinate activities across departments, and monitor change controls within and initiated for the Logistics & Distribution group.
• Manage the creation and subsequent auditing of all warehouse SOP’s, WI’s, forms, and job aides.
• Provide primary support and act as the Subject Matter Expert (SME) to represent the Warehouse in ISO and FDA audits.
• Act as Logistics SME on Inspection Plans (IPs); measuring IPs operational impact, evaluating performance, and finding ways to improve the process.
• Remain current on all Logistics policies and procedures through training and audits of policies and processes for receiving, inspection, and verification of incoming materials.
• Maintain performance and productivity metrics to drive process improvements and ensure visibility to leadership and team.
• Partner closely with Corporate and Clinical Quality as it relates to Supply Chain, Logistics and Distribution activities, ensuring all processes and operations are compliant, with Quality support and contribution.
• Functional lead for quality processes relating to supplier activities, audit programs, investigations, and risk assessments.
• Support ERP activities and expansion, evaluating and leading efforts around Supply Chain and Logistics quality compliance.
• Provide training across the enterprise.
• Conduct quality assessments using key internal and third-party tools to determine strengths and weaknesses and implement corrective actions with location operations teams.
• Use historic, current, and predictive metrics to inform adjustments / decisions.
• Design and implement annual risk assessments to determine level of compliance, create scorecards and develop improvement plans.
• Maintain systems and technology to improve quality programs support logistics safety and adhere to any changing regulatory needs.
• Proven ability to work effectively in team situations, cross-functionally as well as independently.
• Assist with Operations process and improvement projects.
• Excellent oral, written communication, and interpersonal skills.
• Strong documentation skills and attention-to-detail necessary in a GMP and CAP environment.
• Strong analytical and problem-solving skills.
• Ability to adapt to a quickly changing work environment with rapidly changing needs and requests.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Ability to work nights and/or weekends.
• Ability and means to travel between local Abbott locations.
• Ability to travel 20% of working time away from work location, may include overnight/weekend travel.

Required Qualifications

• Bachelor’s degree in Logistics, Supply Chain, Industrial Engineering, or a field outlined in the essential duties; or High School Diploma or General Education Degree (GED) and 4 years of relevant experience as outlined in the essential duties in lieu of Bachelor’s Degree.
• 7+ years of proven experience in operations quality control / assurance.
• 5+ years of experience with warehouse management/ERP systems.
• 3+ years of experience with Quality Management Systems Experience with compliance and quality standards.
• Experience in a laboratory environment, preferably in a GMP, CAP and/or ISO13485 environment.
• Proficiency with MS Office with strong MS Excel skills.
• Results driven work ethic.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.

Preferred Qualifications

• Proficient in Agile, Oracle, SAP, or other Quality Management System and ERP applications.

The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.