Quality Director

Apex Systems; United States; Presencial; USD 150.000 - 190.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality management

Regulatory compliance

Auditing

Leadership

English communication

Educación

Bachelor's degree in a scientific discipline

Herramientas

MS Office

Descripción del empleo

The client Quality Director is responsible for developing, implementing, and maintaining quality assurance and quality control systems, regulatory activities, and related processes to support the manufacture of high-quality products. The role oversees the Quality department’s daily operations and ensures that established procedures are followed, including routine and non-routine testing and analysis of raw materials, in-process items, and finished products.

Key responsibilities include managing staff and coordinating quality and regulatory documentation, compiling data for test procedure documentation, and maintaining testing reporting. The Quality Director maintains equipment calibration systems, reviews compliance data and addresses abnormalities, updates standard operating procedures as required, and formulates and recommends quality assurance policies and programs. The role also conducts audits of key supplier facilities, maintains facility certifications and food safety plans, and manages facility surveys, including information related to processing and supplier facilities, GMP training and internal auditing, and food defense and related preventative programs.

The Quality Director manages regulatory inspections and regulatory filing systems, including documentation accuracy and completeness, and supports regulatory training requirements and compliance with relevant programs. The role oversees change control, customer complaint systems, control document systems (such as batch manufacturing records and labeling-related documentation), and employee training initiatives, including training tied to GMP and change control. The Quality Director is expected to maintain knowledge of applicable regulations and interpret their impact on products, and to travel as required to audit or inspect vendor facilities and to support sales efforts; the position requires a bachelor’s degree in a scientific discipline, typically 5–7 years of experience in quality control and GMP/SOP-driven manufacturing and documentation, experience managing a team, computer literacy in common office tools, and strong English communication skills.