Quality & Regulatory Affairs Director

DHL Supply Chain; Cuautitlán Izcalli; Presencial; Confidencial; Jornada completa

Descripción de la vacante

DHL Supply Chain in Mexico is seeking a senior Quality & Regulatory Leader to design and implement a comprehensive QMS and compliance strategy across Mexico and LATAM. You will oversee audits, certifications, and regulatory inspections to ensure product integrity and regulatory alignment.

The role requires extensive leadership in regulated industries, strong knowledge of GDP/GMP, ISO standards, and cross-functional collaboration to drive continuous improvement and operational excellence.

Formación

• 10+ years of progressive leadership experience in Quality, Compliance, or Regulatory Affairs.
• Experience in pharmaceutical, medical device, healthcare, or regulated logistics industries.
• Proven track record managing regulatory audits, certifications, and continuous improvement.
• Experience leading multidisciplinary teams at national or regional levels.

Responsabilidades

• Define and lead the Quality and Regulatory Affairs strategy for Mexico and LATAM.
• Oversee QMS governance, audits, certifications, and regulatory inspections.
• Manage regulatory licenses, permits, registrations, and agency relations.
• Lead risk assessments and continuous improvement initiatives.

Conocimientos

Quality leadership

Regulatory affairs

Quality systems

ISO 9001

Herramientas

ETQ

iAuditor

Logics

Descripción del empleo

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

Design, define, and implement the integrated Quality, Regulatory Compliance, and Risk Management strategy for DHL Supply Chain operations across Mexico and LATAM, ensuring the effective operation of the Quality Management System (QMS), compliance with national and international regulatory requirements, corporate standards, and customer expectations. Guarantee process standardization through Operational Excellence methodologies while promoting continuous improvement, product integrity, patient safety, operational continuity, and service excellence across regulated industries, including Life Sciences & Healthcare, pharmaceuticals, medical devices, cold chain logistics, transportation, warehousing, packaging, and value-added services.

Key Responsibilities

Quality and Compliance Strategy Leadership

• Define and lead the Quality and Regulatory Affairs strategy for Mexico and LATAM.
• Establish policies, procedures, and corporate standards to ensure regulatory and contractual compliance.
• Serve as the principal advisor on quality, healthcare regulations, and compliance matters across the organization.

Quality Management System (QMS) Governance

• Design, implement, and maintain the Quality Management System for all Supply Chain operations.
• Oversee deviation management, CAPAs, change controls, document management, and risk assessments.
• Ensure effective administration of quality systems and platforms, including ETQ, iAuditor, Logics, and equivalent tools.

Audits, Certifications, and Regulatory Inspections

• Develop and execute the annual internal audit program.
• Lead customer audits, certification audits, and regulatory inspections.
• Manage certifications and recertifications under ISO 9001, ISO 13485, GDP, GMP, and other applicable standards.
• Ensure timely resolution of audit findings and effective implementation of corrective and preventive action plans.

Regulatory Compliance and Licensing

• Ensure the validity and maintenance of operating licenses, permits, registrations, and regulatory authorizations required by national and international authorities.
• Maintain strategic relationships with regulatory agencies and certification bodies.
• Ensure compliance with healthcare regulations applicable to pharmaceuticals, medical devices, and other regulated products.

Operational Quality and Cold Chain Management

• Oversee qualification and validation programs for facilities, computerized systems, critical equipment, and logistics processes.
• Ensure effective management of environmental monitoring systems, IoT technologies, early warning systems, and calibration programs.
• Safeguard product integrity, traceability, and storage and transportation conditions for temperature-sensitive and regulated products.

Risk Management and Continuous Improvement

• Lead operational, regulatory, and business risk assessments.
• Implement continuous improvement initiatives using Lean, Six Sigma, and Operational Excellence methodologies.
• Monitor and analyze key performance indicators (KPIs) to identify improvement opportunities and drive performance.

Organizational Development and Quality Culture

• Design and implement quality and regulatory compliance training and certification programs.
• Foster a \"Compliance First\" culture focused on operational excellence and continuous improvement.
• Lead, mentor, and develop high-performing multidisciplinary teams.

Strategic Business Support

• Participate in RFPs, new business approvals, solution design reviews, and transformation initiatives.
• Conduct regulatory risk assessments for new services, customers, and operational expansions.
• Ensure regulatory compliance and quality requirements are incorporated into new operations from the design phase.

Customs and Trade Compliance Oversight

• Lead risk assessments and compliance initiatives related to Customs & Trade Compliance services.
• Ensure adherence to applicable international trade, customs, and import/export regulations.

Who we are looking for

• Minimum 10 years of progressive leadership experience in Quality, Compliance, or Regulatory Affairs functions.
• Proven experience within pharmaceutical, medical device, healthcare, regulated manufacturing, or specialized logistics industries.
• Extensive experience managing regulatory audits, certification programs, and continuous improvement initiatives.
• Demonstrated success leading multidisciplinary teams at national or regional levels.
• Strong experience in warehousing, transportation, cold chain logistics, and value-added services operations.
• Quality Management Systems (QMS).
• Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP).
• ISO 9001 and ISO 13485 standards.
• Risk Management, CAPA, Change Control, and Deviation Management.
• Computerized System Validation (CSV) and infrastructure qualification.
• Cold Chain Management and environmental monitoring systems.
• National and international healthcare regulations.
• Customs & Trade Compliance.
• Lean, Six Sigma, and Operational Excellence methodologies.
• Experience with ETQ, iAuditor, Logics, and equivalent quality management platforms.
• Strategic leadership and business acumen.
• Executive influencing and stakeholder management.
• Customer focus and relationship management.
• Strong analytical and problem-solving skills.
• Negotiation and regulatory engagement capabilities.
• Talent development and team coaching.
• Advanced English proficiency (C1 level or higher) required.
• Availability to work in Cuatitlán Izcalli.

Connecting people, improving lives.