Quality Manager | Pharmaceutical Warehouse Operations
DHL · Cuautitlán Izcalli
About DHL Supply Chain:
As the world’s largest contract logistics specialist, we create a competitive advantage for our customers by giving them logistics solutions based on our globally standardized warehousing, transportation, and integrated services.
Our people is our biggest asset. We are certified as a Great Place to Work Company. In DHL you will find a culture that embraces diversity, collaboration; boost your strengths and generate confidence.
A world driven by logistic. A company driven by people!
Job Purpose:
Lead and ensure the execution of the Quality Management System (QMS) for pharmaceutical warehouse operations, guaranteeing compliance with regulatory requirements, customer standards, Good Distribution Practices (GDP), and DHL policies. The role is responsible for maintaining product integrity, regulatory compliance, audit readiness, cold chain controls, and continuous improvement initiatives, while promoting a strong quality culture across site operations.
Key Responsibilities
Quality Management System (QMS)
- Ensure effective implementation and maintenance of the site's Quality Management System.
- Manage deviations, CAPAs, change controls, risk assessments, investigations, and document control processes.
- Monitor quality metrics and drive corrective actions to ensure compliance and operational effectiveness.
- Maintain SOPs, work instructions, and quality documentation in line with regulatory and customer requirements.
Regulatory Compliance & GDP/GMP Oversight
- Ensure compliance with applicable pharmaceutical regulations, GDP requirements, customer quality agreements, and corporate standards.
- Support the maintenance of site licenses, permits, and regulatory documentation required for pharmaceutical operations.
- Act as the primary quality representative during interactions with customers, regulatory authorities, and certification bodies.
- Stay updated on regulatory changes and ensure timely implementation within the operation.
Audits and Inspections
- Lead internal audit programs and self-inspections across warehouse operations.
- Coordinate and support customer audits, regulatory inspections, and certification audits.
- Ensure effective closure of audit observations through robust CAPA implementation.
- Maintain a permanent state of inspection readiness.
Operational Quality & Product Integrity
- Ensure product integrity throughout receiving, storage, picking, packing, and distribution processes.
- Oversee temperature-controlled operations, environmental monitoring programs, calibration activities, and cold chain compliance.
- Monitor traceability, stock accuracy, batch control, and inventory management processes.
- Ensure compliance with qualification and validation requirements for facilities, equipment, and operational processes.
Risk Management & Continuous Improvement
- Conduct quality risk assessments for operational changes, new customers, new products, and process modifications.
- Utilize Lean, Six Sigma, and Operational Excellence tools to drive continuous improvement initiatives.
- Analyze quality trends, KPI performance, and customer feedback to identify improvement opportunities.
- Lead root cause investigations and implement preventive actions to reduce quality incidents.
Customer & Stakeholder Management
- Serve as the primary point of contact for customer quality-related matters.
- Participate in business reviews, customer governance meetings, and operational excellence initiatives.
- Support new business implementations by ensuring quality and compliance requirements are incorporated from the design phase.
- Build strong relationships with Operations, HSE, Engineering, IT, and customer quality teams.
People Leadership & Quality Culture
- Lead and develop the site Quality team, ensuring high performance and succession planning.
- Deliver quality training programs and ensure operational teams maintain required certifications and competencies.
- Promote a "Quality First" culture focused on compliance, accountability, and continuous improvement.
- Coach operational leaders in quality and regulatory best practices.
Who We Are Looking For:
Experience
- Minimum 5-8 years of experience in Quality Management within pharmaceutical warehousing, distribution, logistics, or healthcare operations.
- Proven experience managing pharmaceutical quality systems in regulated environments.
- Experience leading customer audits, regulatory inspections, and certification programs.
- Strong background supporting warehouse operations, inventory management, and cold chain logistics.
- Previous leadership experience managing quality teams and cross-functional stakeholders.
Technical Knowledge
- Quality Management Systems (QMS).
- Good Distribution Practices (GDP).
- Good Manufacturing Practices (GMP) knowledge.
- CAPA, Change Control, Deviations, Investigations, and Risk Management.
- Pharmaceutical warehouse operations and distribution processes.
- Cold Chain Management and temperature monitoring systems.
- Qualification and Validation concepts.
- Root Cause Analysis methodologies.
- ISO 9001 and pharmaceutical quality standards.
- Experience using quality management platforms such as ETQ, TrackWise, iAuditor, or equivalent systems.
- Lean, Six Sigma, and Continuous Improvement methodologies.
Leadership Competencies
- Strong people leadership and team development capabilities.
- Customer-focused mindset with strong stakeholder management skills.
- Excellent analytical and problem-solving abilities.
- Ability to influence operational leaders and drive compliance culture.
- Strong communication and presentation skills.
- Effective decision-making in fast-paced operational environments.
Requirements
- Bachelor's Degree in Pharmacy, Chemistry: QFB, QFI
- Advanced English proficiency required.
- Availability to work onsite in Cuautitlán Izcalli and Tepotzotlan.
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