Quality Control Lead - GMP, Compliance & CI

Swiss American CDMO; Carrollton (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Swiss American CDMO in Carrollton, TX is seeking an Assistant Quality Control Manager to lead a 15+ person QC team and ensure compliance with GMP, FDA regulations, and company SOPs. The role supports raw material inspection, environmental monitoring, investigations, CAPA, and continuous improvement initiatives.

We are looking for a proactive leader with strong analytical, communication, and organizational skills who can manage multiple priorities across departments and drive audit readiness and

Qualifications

• Experience in Quality Control, Quality Assurance, or a related manufacturing environment.
• Knowledge of GMP, FDA regulations, quality systems, and audit processes.
• Strong analytical, problem-solving, organizational, and communication skills.
• Ability to manage multiple priorities and work effectively across departments.
• Bachelor's degree in a related field preferred.
• Prior leadership or supervisory experience preferred.

Responsibilities

• Assist in leading a Quality Control team of 15+ employees, including supervisors and quality associates.
• Oversee raw material receiving, inspection, release activities, and nonconforming material investigations.
• Support environmental monitoring, water sampling, temperature monitoring, and dose audit programs.
• Coordinate testing activities with third-party laboratories and ensure timely follow-up of results.
• Investigate quality events, process deviations, and product quality issues and assist with corrective actions.
• Support CAPA development, implementation, and effectiveness reviews.
• Ensure compliance with SOPs, FDA regulations, GMP requirements, and internal quality standards.
• Monitor Quality Management System (QMS) activities and identify opportunities for continuous improvement.
• Assist with KPI reporting, employee scheduling, performance management, and audit readiness activities.

Skills

Quality control

Quality assurance

GMP knowledge

FDA regulations

Analytical skills

Problem solving

Communication

Organizational skills

Multitasking

Leadership experience

Education

Bachelor's degree in a related field

Job description

Swiss American CDMO in Carrollton, TX is seeking an Assistant Quality Control Manager to lead a 15+ person QC team and ensure compliance with GMP, FDA regulations, and company SOPs. The role supports raw material inspection, environmental monitoring, investigations, CAPA, and continuous improvement initiatives.

We are looking for a proactive leader with strong analytical, communication, and organizational skills who can manage multiple priorities across departments and drive audit readiness and