National Quality Manager

Joinimagine

Hebron Estates (KY)

On-site

USD 106,000 - 141,000

Full time

4 days ago
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Benefits offered by this job

Stock purchase plan
401(k) match
Medical coverage
Vision coverage
Dental coverage
Paid time off

Job summary

DHL Global Forwarding is seeking a National Quality Manager for the AFR Team to lead the Life Sciences and Healthcare QMS across US operations, with a focus on GxP compliance and regulatory alignment.

You will oversee audits, CAPA processes, and temperature-controlled logistics while collaborating with Operations, Sales, and Warehouse teams to support onboarding and tender activities.

Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field.
  • 5–8 years of experience in Quality Assurance in GxP environments.
  • Strong knowledge of GDP, GMP, ISO 9001, ISO 13485.
  • Proven audit management, QMS implementation, and CAPA experience.
  • Knowledge of cold chain logistics or clinical trial supplies is a plus.
  • Strong leadership, communication, and cross-functional collaboration.

Responsibilities

  • Maintain and improve the local GxP-compliant QMS per regulatory standards.
  • Lead audits and regulatory inspections.
  • Monitor CAPA, deviations, change control, and risk assessments.
  • Oversee temperature mapping, calibration, and cold chain integrity.
  • Train staff on GxP procedures and quality standards.
  • Serve as primary contact for pharma/healthcare customers on quality topics.
  • Support tenders and RFPs with quality inputs and certifications.
  • Prepare quality reports for senior leadership.

Skills

GxP knowledge
Audit management
QMS implementation
CAPA processes
Leadership
Cross-functional collaboration
English fluent

Education

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field
Advanced degree a plus

Job description

Job Title: National Quality Manager
Job Location: Hebron, Kentucky

We have an exciting opportunity for a National Quality Manager for our AFR Team. The National Quality Manager to lead and oversee the Life Sciences and Healthcare (LSH) Quality Management System (QMS) across all operations within the United States. This role ensures full compliance with GxP (Good Practices: GDP, GMP, GSP, etc.) standards, regulatory requirements, and customer expectations. The ideal candidate will serve as a key quality interface between global HQ, regional stakeholders, regulatory authorities, and clients within the pharmaceutical, biotech, and medical device sectors.

Key Responsibilities
  • Maintain and continuously improve the local GxP-compliant Quality Management System (QMS) aligned with national and global standards and local regulatory requirements (e.g., FDA, EMA, WHO, MHRA).
  • Ensure compliance with Good Distribution Practices (GDP) and other applicable quality standards throughout transportation, warehousing, and handling of temperature-sensitive and critical healthcare shipments.
  • Lead preparation, execution, and follow-up of internal, external, and customer audits, including regulatory inspections.
  • Monitor CAPA implementation, deviation handling, change control processes, and risk assessments.
  • Conduct regular site inspections and quality reviews across branches and logistics hubs.
  • Develop and implement GxP training programs for operational and warehouse teams.
  • Promote a strong quality culture through education, mentoring, and leadership.
  • Act as primary point of contact for pharma/healthcare customers regarding quality-related topics.
  • Collaborate with cross-functional teams (Operations, Sales, Warehouse) to support customer onboarding and SOP development.
  • Support tenders and RFPs with quality inputs and certifications.
  • Track and analyze KPI trends, deviations, audit findings, and improvement projects.
  • Prepare and present quality reports for senior leadership.
  • Manage temperature mapping and qualification activities for cool rooms, freezers, and temperature-controlled warehouse areas.
  • Develop and maintain mapping protocols, validation reports, SOPs, and compliance documentation in line with GDP and regulatory requirements.
  • Oversee calibration and maintenance of temperature monitoring equipment and data loggers.
  • Analyze mapping data, investigate temperature excursions, and implement CAPA actions.
  • Ensure continuous environmental monitoring and cold chain integrity across warehouse operations.
  • Coordinate with operations, engineering, vendors, and customers to support audits, inspections, and compliance activities.
  • Conduct risk assessments related to temperature-controlled storage and transport conditions.
  • Support staff training on temperature control procedures and quality standards.
Skills / Requirements
  • Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field (advanced degree a plus).
  • Minimum 5–8 years of experience in Quality Assurance in GxP-regulated environments (pharma, biotech, or healthcare logistics).
  • In-depth understanding of GDP, GMP, ISO 9001, ISO 13485, and other regulatory frameworks.
  • Demonstrated experience in audit management, QMS implementation, and CAPA processes.
  • Knowledge of cold chain logistics, controlled substances handling, or clinical trial supplies is a strong advantage.
  • Strong leadership, communication, and cross-functional collaboration skills.
  • Fluent in English (spoken and written); additional language skills a plus.

Pay Range: $105,682.50 - $140,910.00+ (Based on Experience)

Benefits (All Non-Union Employees)
  • Compensation: Competitive base salary plus role dependent performance-based incentives.
  • 401(k) Match: $1-for-$1 match up to 4% quarterly + 2% annual base contribution.
  • Stock Purchase Plan: Ability to purchase Deutsche Post AG shares at a discounted rate.
  • Medical: Comprehensive plans covering preventive care, inpatient/outpatient services, and prescriptions.
  • Vision: Optional coverage for exams, frames, and contacts.
  • Dental: Optional coverage for preventive, basic, and major services.
  • Paid Time Off: 7 major holidays, 8 floating holidays, and accrued vacation/sick days.
Why Join DHL Global Forwarding?

At DHL Global Forwarding, we invest in our employees’ growth, providing training, guidance, and career advancement opportunities. We believe in building careers, not just jobs, and empowering our team to develop skills and achieve long-term success.

Be part of DHL Group, the world’s leading logistics provider, operating in 220+ countries. DHL Global Forwarding (DGF) is a global leader in air and ocean freight, with 30,000+ employees ensuring seamless transport and supply chain solutions. Explore careers with us: DHL Careers.

Equal Opportunity Employer

DHL Global Forwarding is committed to equal employment opportunities, evaluating all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.

Work Authorization

Applicants must be legally authorized to work in the United States. Visa sponsorship is not available for this role.

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