Warehouse Quality Systems & Facilities Manage

Position Summary

Hongene is seeking a Warehouse Quality Systems & Facilities Manager to lead the development, implementation, and ongoing maintenance of the ISO 9001 Quality Management System (QMS) for our Union City warehouse and logistics operations. This will be an individual contributor.

This role will also own quality document control, support warehouse quality and compliance activities, and coordinate facility maintenance and critical equipment programs. The ideal candidate is a hands-on quality professional with practical experience building or improving ISO 9001 systems in warehouse, logistics, or related operational environments.

Key Responsibilities

• Lead the development, implementation, and continuous improvement of the ISO 9001 Quality Management System for warehouse and logistics operations.
• Lead ISO 9001 certification readiness, internal audits, corrective actions, and ongoing audit compliance.
• Own quality document control, including SOPs, work instructions, forms, quality records, revisions, and periodic reviews.
• Manage key quality processes, including deviations, CAPA, change control, complaints, and training compliance.
• Partner with Operations to ensure receiving, quarantine, storage, inventory handling, packing, shipping, and temperature-controlled material handling are performed in accordance with approved procedures.
• Support investigation and follow-up of warehouse quality events, including temperature excursions, shipping issues, and inventory discrepancies.
• Coordinate preventive maintenance, calibration, service, and documentation for critical equipment and facility systems.
• Manage facility-related vendors, repairs, inspections, and improvement activities.
• Support site safety, emergency preparedness, regulatory compliance, and continuous improvement initiatives.
• Work cross-functionally with Operations, Laboratory, Administration, IT, and other teams to implement quality and facility programs.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Quality, Operations, Supply Chain, or a related field.
• 5+ years of relevant experience in quality systems, quality assurance, warehouse quality, logistics compliance, or related operations.
• Hands-on experience implementing, maintaining, or significantly improving an ISO 9001 Quality Management System.
• Experience with document control, SOPs, deviations, CAPA, change control, audits, and training records.
• Strong organizational, communication, and project management skills.
• Ability to work independently and influence cross-functional teams without direct reporting authority.

Preferred Qualifications

• Experience establishing or implementing ISO 9001 within warehouse, logistics, distribution, or temperature-controlled operations.
• Experience in biotechnology, pharmaceutical, life sciences, chemical, medical device, or another regulated industry.
• ISO 9001 Internal Auditor or Lead Auditor training or certification.
• Experience with cold storage, environmental monitoring, critical equipment, facility systems, or calibration programs.
• Experience with electronic document management systems or eQMS.
• Ability to communicate in Mandarin Chinese is a plus.