Warehouse Quality Systems & Facilities Manage

Hongene Biotech Corporation; Union City (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Hongene Biotech Corporation in Union City, CA is seeking a Warehouse Quality Systems & Facilities Manager to lead the ISO 9001 QMS for our warehouse and logistics operations. This role is an individual contributor and focuses on quality systems, document control, and facility maintenance.

You will drive certification readiness, audits, CAPA, and improve procedures across receiving, storage, and shipping, ensuring compliance with regulatory standards.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Quality, Operations, or related field.
• 5+ years of experience in quality systems, QA, or warehouse quality.
• Hands-on ISO 9001 implementation and maintenance experience.
• Experience with document control, SOPs, deviations, CAPA, change control, audits, and training records.
• Strong organizational and project management skills.
• Ability to influence cross-functional teams without direct reports.

Responsibilities

• Lead ISO 9001 QMS development, implementation, and continuous improvement 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.

Skills

Quality management

ISO 9001

Document control

Audits

CAPA

Project management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in Life Sciences, Engineering, Quality, Operations, or a related field

Tools

eQMS

SOP management software

Job description

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.