Quality Leader for FDA-Regulated Manufacturing

Nulixir Inc.; Austin (TX); On-site; USD 120,000 - 160,000; Full time

Job summary

Nulixir Inc. seeks an experienced Quality Manager to lead the Quality function at the Austin manufacturing facility. You will own QA/QC, maintain the Quality Management System, and ensure compliance with FDA, cGMP, food safety and customer requirements.

This hands-on leader will oversee product release, supplier quality, deviations, CAPAs and audits on the manufacturing floor. The role requires 7+ years in FDA-regulated QA/QC with 3+ years in leadership, plus a strong track record building

Qualifications

• Bachelor's degree in a relevant scientific or technical discipline.
• 7+ years of progressive Quality Assurance/Quality Control experience in FDA-regulated manufacturing.
• 3+ years of Quality leadership or management experience.
• Strong working knowledge of FDA cGMP requirements and Quality systems in regulated manufacturing.

Responsibilities

• Serve as the senior onsite Quality authority for Nulixir's Austin manufacturing operations.
• Own and continuously improve the site's Quality Management System in accordance with FDA, cGMP, food safety and customer requirements.
• Lead, train and develop Quality Technicians and other Quality personnel.
• Establish Quality priorities and ensure coverage across receiving, manufacturing, testing and finished-product release.
• Review and approve SOPs, specifications, work instructions, forms and Quality records.
• Maintain document-control, record-retention and Quality training systems.
• Conduct routine floor inspections and internal audits.
• Establish and monitor Quality KPIs and communicate risks and CAPA status to leadership.

Skills

Quality leadership

FDA compliance

QMS management

Batch release

Root cause analysis

Education

Bachelor's degree in Food Science, Microbiology, Chemistry, Biology, Quality, Engineering

Job description

Nulixir Inc. seeks an experienced Quality Manager to lead the Quality function at the Austin manufacturing facility. You will own QA/QC, maintain the Quality Management System, and ensure compliance with FDA, cGMP, food safety and customer requirements.

This hands-on leader will oversee product release, supplier quality, deviations, CAPAs and audits on the manufacturing floor. The role requires 7+ years in FDA-regulated QA/QC with 3+ years in leadership, plus a strong track record building