Onsite Quality Leader: Build Scalable GMP Systems

Formulate Labs; St. Louis (MO); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Leadership role with direct influence

Quality system development

Hands-on impact in manufacturing

Job summary

Formulate Labs in St. Louis, MO is seeking a hands-on Quality Manager to own the quality systems across raw materials, production, finished goods, and documentation. You will lead, standardize SOPs, CAPA, and audits in a modern, automation-driven facility.

This is an onsite leadership role focused on scalable, auditable quality processes with cross-functional collaboration to reduce defects and ensure regulatory compliance.

Qualifications

• 4+ years in quality management within a manufacturing environment.
• Strong understanding of quality systems, documentation control, and deviation management.
• Experience with GMP, ISO-style systems, or regulated manufacturing environments.

Responsibilities

• Own and maintain the facility's quality management systems.
• Develop and update SOPs, batch documentation standards, and inspection protocols.
• Oversee incoming material inspection, in-process checks, and finished goods approval.
• Lead root cause investigations and corrective/preventative actions (CAPA).
• Ensure compliance with applicable regulatory and safety standards.
• Train and mentor Quality Control Technicians and production staff on quality procedures.
• Monitor key quality metrics and drive continuous improvement initiatives.
• Partner with Operations and Engineering to improve process robustness and reduce defects.
• Support audits, customer quality requests, and documentation requirements.

Skills

Quality management

Documentation control

CAPA

GMP/ISO

Job description

Formulate Labs in St. Louis, MO is seeking a hands-on Quality Manager to own the quality systems across raw materials, production, finished goods, and documentation. You will lead, standardize SOPs, CAPA, and audits in a modern, automation-driven facility.

This is an onsite leadership role focused on scalable, auditable quality processes with cross-functional collaboration to reduce defects and ensure regulatory compliance.