Pharma Quality Systems Leader – QMS & Compliance

Guerbet; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

Guerbet seeks an experienced Quality Systems Manager to lead the QMS within a regulated pharmaceutical manufacturing environment in the United States. You will oversee change control, document management, training, data integrity, supplier quality, APQR, and risk management, ensuring compliance and continuous improvement.

You will partner with Manufacturing, Validation, Regulatory Affairs, R&D and Operational Excellence to align quality systems with business needs and drive sustainable

Qualifications

• 7+ years of pharmaceutical QA/quality assurance experience.
• 3+ years of Quality Systems leadership experience.
• Strong knowledge of cGMP, 21 CFR Parts 210/211, EU GMP, ICH Q10.

Responsibilities

• Lead the execution and continuous improvement of the QMS.
• Oversee change control, document management, training, data integrity, supplier quality, APQR, and risk management.
• Prepare for internal audits and regulatory inspections and coordinate CAPA closures.
• Collaborate with Manufacturing, Regulatory Affairs, R&D, and Ops to integrate QMS across site operations.
• Develop and mentor Quality Systems team members.

Skills

Quality Systems Leadership

cGMP Knowledge

Regulatory Inspections

Data Integrity

Cross-functional Collaboration

Education

Bachelor's degree in Life Sciences/Engineering/Pharmacy

Tools

eQMS

Job description

Guerbet seeks an experienced Quality Systems Manager to lead the QMS within a regulated pharmaceutical manufacturing environment in the United States. You will oversee change control, document management, training, data integrity, supplier quality, APQR, and risk management, ensuring compliance and continuous improvement.

You will partner with Manufacturing, Validation, Regulatory Affairs, R&D and Operational Excellence to align quality systems with business needs and drive sustainable