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Ensure full compliance with the Quality Management System (QMS) for pharmaceutical warehousing and transportation operations by adhering to applicable regulatory requirements, customer contractual obligations, and industry best practices. The role is responsible for safeguarding the integrity, safety, and quality of pharmaceutical and biotechnological products throughout the supply chain. This position will drive the achievement of contractual quality KPIs, lead deviation and complaint investigations, ensure CAPA effectiveness, and enhance customer experience through proactive quality management, technical expertise, and continuous improvement initiatives.

Quality Management System (QMS)

• Manage and maintain the Quality Management System in accordance with regulatory, corporate, and customer requirements.
• Ensure timely updates of Standard Operating Procedures (SOPs), work instructions, forms, and controlled documentation.
• Oversee change controls, deviations, customer complaints, CAPAs, and document control processes.
• Ensure compliance with agreed Service Level Agreements (SLAs) and quality-related response timelines.

Customer Quality Performance & Experience

• Maintain and achieve contractual quality KPIs, including:
  • Deviation investigation turnaround times.
  • Complaint response and closure timelines.
  • CAPA implementation and effectiveness.
  • Compliance with quality SLAs.
• Drive continuous improvement initiatives aimed at enhancing customer satisfaction and quality performance metrics.
• Act as the primary quality liaison with regional and global customer quality teams.
• Support improvements in customer quality perception by ensuring timely resolutions, robust investigations, and prevention of recurring issues.

Product Release & Pharmaceutical Operations

• Coordinate product sampling activities and shipment of samples for laboratory testing and product release.
• Ensure product release activities are performed according to established procedures and contractual timelines.
• Verify compliance with Good Storage and Distribution Practices across all warehouse and transportation operations.

Cold Chain Management

• Ensure compliance with cold chain storage and transportation requirements.
• Monitor and maintain product integrity through temperature-controlled environments, continuous monitoring systems, and excursion management processes.
• Ensure proper operation and qualification of cold rooms, monitoring devices, and refrigerated transportation equipment.

Regulatory Compliance & Audits

• Lead preparation and support during internal, customer, corporate, and regulatory audits.
• Participate in inspections conducted by health authorities and regulatory agencies, including COFEPRIS.
• Manage audit observations, corrective action plans, and timely closure of findings.
• Ensure compliance with:
  • NOM-059-SSA1 (Good Manufacturing Practices)
  • NOM-241-SSA1
  • ISO 9001
  • Good Storage and Distribution Practices (GSDP)

Project Participation

• Participate in business expansion, new customer implementations, operational growth, and continuous improvement projects.
• Assess quality risks associated with operational changes and new processes.
• Ensure quality requirements are integrated into project planning and execution.
• Monitor and mitigate impacts on product quality and customer service during project implementation.

Leadership & Team Management

• Lead and develop quality personnel while promoting a culture of compliance, accountability, and continuous improvement.
• Facilitate cross-functional collaboration and conflict resolution.
• Coach team members in quality investigation methodologies and root cause analysis techniques.
• Drive effective problem-solving and preventive action implementation.