QHSE Healthcare Expert - Chicago, IL

CMA CGM • Chicago, IL

1d • $120,000 - $130,000 • Onsite

About The Position

The purpose of this role is to lead and strengthen the Healthcare Quality Management System across NORTAM by ensuring compliance with applicable regulatory, customer, ISO, GDP/GMP, and internal QMS requirements. The position supports healthcare operations in maintaining product integrity, audit readiness, effective CAPA management, controlled documentation, training compliance, supplier management and continuous improvement to enable safe, compliant, and reliable healthcare logistics services across all the products managed (Air, Ground, Ocean &CL).

Requirements

• Bachelor’s degree in quality, Life Sciences, Pharmacy, Engineering, Supply Chain, Healthcare, Logistics, or a related field required; advanced degree preferred.
• Minimum 5 years of experience in healthcare quality, pharmaceutical, medical device, life sciences, regulated logistics, or related quality management environments preferred.
• Demonstrated experience supporting or leading QMS implementation, audits, CAPA, training compliance, supplier qualification, and customer quality requirements.
• Knowledge of ISO 9001, ISO 13485, GDP, GMP, regulatory expectations, and healthcare logistics compliance requirements.
• Internal Auditor or Lead Auditor certification preferred.
• Experience in multi-site, regional, or cross-functional quality support roles preferred.
• Strong analytical, communication, and problem-solving skills.
• Strong knowledge of Quality Management Systems, including ISO 9001, ISO 13485, GDP, GMP, and applicable healthcare regulatory requirements.
• Experience with audits, inspections, CAPA, nonconformance management, root cause analysis, change control, supplier quality, and risk management.
• Ability to manage controlled documentation, training matrices, quality records, SOPs, work instructions, and evidence of compliance.
• Working knowledge of product integrity controls, temperature-controlled logistics, healthcare storage and distribution requirements, and customer-specific quality expectations.
• Proficiency in quality metrics, KPI monitoring, trend analysis, reporting, and continuous improvement tools.
• Experience using quality management platforms, document control systems, Microsoft Office tools, SharePoint, and data reporting tools.
• Strong communication skills with the ability to explain quality and regulatory requirements clearly to operational and leadership teams.
• Customer-focused mindset with the ability to balance compliance, operational needs, and service expectations.
• High sense of ownership, urgency, accountability, and attention to detail.
• Ability to influence without direct authority and build effective relationships across functions, sites, customers, and suppliers.
• Strong analytical thinking, problem-solving capability, and decision-making under pressure.
• Adaptability, resilience, and ability to manage competing priorities in a fast-paced, regulated environment.
• Collaborative leadership style that promotes trust, engagement, coaching, and continuous learning.
• Ability to translate complex healthcare regulatory and quality requirements into practical operational controls.
• Strong capability to support healthcare business growth by identifying quality requirements during new business implementation, customer onboarding, and operational changes.
• Ability to assess quality risks, define mitigation actions, and drive timely closure of compliance gaps.
• Experience developing or enhancing healthcare-specific procedures, training programs, supplier controls, and audit readiness tools.
• Demonstrated ability to lead cross-functional initiatives involving operations, account management, business development, procurement, suppliers, and regional QHSE leadership.
• Strategic mindset with the ability to strengthen QMS maturity, standardization, product integrity, and customer confidence across multiple locations.

Nice To Haves

• advanced degree preferred
• Minimum 5 years of experience in healthcare quality, pharmaceutical, medical device, life sciences, regulated logistics, or related quality management environments preferred.
• Internal Auditor or Lead Auditor certification preferred.
• Experience in multi-site, regional, or cross-functional quality support roles preferred.

Responsibilities

• Maintain and continuously improve the Healthcare QMS, ensuring alignment with global, regional, regulatory, and customer requirements.
• Provide quality leadership and technical guidance to healthcare operations, account management, business development, and site teams.
• Ensure healthcare-controlled documentation, SOPs, work instructions, records, and management practice records are current, controlled, and effectively implemented.
• Coordinate audit readiness activities, including internal audits, customer audits, supplier audits, regulatory inspections, and follow-up actions.
• Lead or support investigations, nonconformance management, root cause analysis, CAPA implementation, and effectiveness verification.
• Support product integrity controls, including temperature-controlled storage, handling, transportation, returns, recalls, and risk mitigation activities.
• Monitor quality metrics, customer feedback, CAPA trends, audit results, training compliance, and site deliverables to identify improvement opportunities.
• Support supplier qualification, supplier performance monitoring, and healthcare-specific supplier quality requirements.
• Promote a culture of compliance, patient safety, right-first-time execution, accountability, and continuous improvement across healthcare operations.
• Maintain the Healthcare QMS and associated documentation.
• Ensure compliance with applicable regulatory, customer, and quality requirements.
• Support licensing and regulatory compliance activities.
• Monitor regulatory changes and communicate impacts to healthcare operations and leadership.
• Assist sites in maintaining audit and inspection readiness.
• Coordinate internal, customer, supplier, and regulatory audits.
• Lead investigations of quality issues and nonconformances.
• Manage Corrective and Preventive Actions (CAPA) and verify effectiveness.
• Support the safe storage, handling, and distribution of healthcare products.
• Monitor quality controls affecting product integrity, including temperature-controlled processes.
• Participate in risk assessments and mitigation activities.
• Identify quality-related training requirements.
• Support training matrix management and employee competency programs.
• Verify completion and effectiveness of required training.
• Act as a quality contact for healthcare customers and operations teams.
• Support implementation of customer requirements, SOPs, and operational changes.
• Participate in quality reviews and customer meetings.
• Analyze quality metrics and trends.
• Drive initiatives to improve compliance, efficiency, and customer satisfaction.
• Promote a culture of quality and continuous improvement.

Benefits

• competitive Paid Time Off
• 401(k)
• health insurance
• employee benefits platform that offers discounts on gym memberships and a diverse range of retail, travel, car and hospitality brands
• pet insurance
• multiple health plans(company contribution to health savings account)
• prescription, dental and vision coverage
• Company paid life insurance, accident insurance, short- and long-term disability coverage and employee assistance plan.
• Voluntary benefits including additional life insurance, AD&D coverage, buy-up short- and long-term disability, critical illness, identify theft & legal plan.
• 401(k) with company match.
• Flexible Paid Time Off programs including company paid holidays.
• Tuition reimbursement program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior