ISO 9001 Quality & Facilities Lead - Warehouse

Hongene-Biotech-Corporation; Union City (CA); On-site; USD 95,000 - 150,000; Full time

Job summary

Hongene is seeking a Warehouse Quality Systems & Facilities Manager in Union City, CA to lead the development, implementation, and ongoing maintenance of the ISO 9001 Quality Management System for our warehouse and logistics operations. This will be an individual contributor role focused on quality and facilities programs.

The ideal candidate has hands-on experience building or improving ISO 9001 systems in warehouse or logistics settings, with strong document control, CAPA, audits, and

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.

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.

Skills

Quality management

ISO 9001

Cross-functional collaboration

Document control

Education

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

Job description

Hongene is seeking a Warehouse Quality Systems & Facilities Manager in Union City, CA to lead the development, implementation, and ongoing maintenance of the ISO 9001 Quality Management System for our warehouse and logistics operations. This will be an individual contributor role focused on quality and facilities programs.

The ideal candidate has hands-on experience building or improving ISO 9001 systems in warehouse or logistics settings, with strong document control, CAPA, audits, and