Quality Systems Leader, GMP & Regulatory Readiness

Guerbet; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Continued personal development

Diversity and inclusion initiatives

Job summary

Guerbet in Raleigh, North Carolina is seeking a Quality Systems Manager to oversee the execution and continuous improvement of its Quality Management System (QMS). The successful candidate will ensure compliance with global regulatory standards while driving a culture of quality throughout the organization.

The role requires at least 7 years in pharmaceutical QA, including 3 years in leadership, along with a Bachelor's degree in a relevant field. Join Guerbet and contribute to enhancing patient outcomes through innovation.

Qualifications

• 7+ years of experience in pharmaceutical QA, with 3+ years in quality systems leadership.
• Deep understanding of GMP regulations (21 CFR Parts 210/211, EU Annexes, ICH Q10).
• Proven experience managing audits and regulatory inspections.

Responsibilities

• Oversee the execution and continuous improvement of Guerbet's Quality Management System (QMS).
• Ensure compliance with global regulatory requirements (e.g., FDA, EMA, ANVISA, PIC/S).
• Drive a culture of quality across the organization.

Skills

Analytical skills

Organizational skills

Communication skills

Understanding of GMP regulations

Education

Bachelor’s degree in Life Sciences, Engineering, or related field

Tools

Electronic QMS platforms

Job description

Guerbet in Raleigh, North Carolina is seeking a Quality Systems Manager to oversee the execution and continuous improvement of its Quality Management System (QMS). The successful candidate will ensure compliance with global regulatory standards while driving a culture of quality throughout the organization.

The role requires at least 7 years in pharmaceutical QA, including 3 years in leadership, along with a Bachelor's degree in a relevant field. Join Guerbet and contribute to enhancing patient outcomes through innovation.