Quality & Compliance Director (GMP & Audits)

Apex Systems; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Apex Systems is seeking a Quality Director to develop, implement, and maintain QA and QC systems across GMP-driven manufacturing processes. The role oversees the Quality department’s daily operations, ensuring procedures are followed and testing is analyzed for raw materials, in-process items, and finished products.

The position leads regulatory activities, supplier facility audits, and training on GMP and change control, with travel as required to support audits, inspections, and sales efforts.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 5–7 years of experience in quality control and GMP/SOP-driven manufacturing and documentation.
• Experience managing a team.
• Strong English communication skills.
• Willingness to travel for audits and inspections.

Responsibilities

• Develop, implement, and maintain QA and QC systems across GMP-driven manufacturing processes.
• Oversee the Quality department’s daily operations and testing of materials and products.
• Coordinate quality and regulatory documentation and data compilation for procedures.
• Lead supplier facility audits and maintain facility certifications and food safety plans.
• Support regulatory inspections, change control, and training on GMP requirements.

Skills

Quality management

Regulatory compliance

Auditing

Leadership

English communication

Education

Bachelor's degree in a scientific discipline

Tools

MS Office

Job description

Apex Systems is seeking a Quality Director to develop, implement, and maintain QA and QC systems across GMP-driven manufacturing processes. The role oversees the Quality department’s daily operations, ensuring procedures are followed and testing is analyzed for raw materials, in-process items, and finished products.

The position leads regulatory activities, supplier facility audits, and training on GMP and change control, with travel as required to support audits, inspections, and sales efforts.