Quality System Manager

JCW Group; Philadelphia (Philadelphia County); On-site; USD 120,000 - 170,000; Full time

Job summary

JCW Group seeks a QMS Manager to join its quality organization at a global pharmaceutical CDMO. You will oversee quality systems, internal and external audits, and inspection readiness in a fast-paced manufacturing environment.

Ideal candidates have 8+ years of QMS experience in pharma/biotech or a regulated setting, 3+ years of management, plus strong GMP knowledge and proven FDA inspection support. CDMO experience is strongly preferred.

Qualifications

• 8+ years of QMS experience in pharma/biotech or regulated environments
• 3+ years of management experience
• Strong experience with internal/external audits and FDA inspection readiness
• Hands-on experience supporting FDA inspections, front-room and back-room activities
• Strong GMP and quality systems knowledge
• CDMO experience strongly preferred
• Bachelor's degree in a relevant scientific discipline

Responsibilities

• Oversee quality management systems and documentation
• Coordinate internal and external audits
• Prepare and support FDA inspections and regulatory readiness
• Ensure inspection readiness across operations

Skills

QMS experience

Management experience

Audits & FDA readiness

GMP knowledge

CDMO experience

Education

Bachelor's degree in a relevant scientific discipline

Job description

A global pharmaceutical CDMO is looking to add a QMS Manager to its quality organization. This role will oversee quality systems, internal and external audits, and inspection readiness within a fast-paced manufacturing environment.

We're looking for candidates with:

• 8+ years of QMS experience in pharma, biotech, or a similarly regulated environment
• 3+ years of management experience
• Strong experience with internal/external audits and FDA inspection readiness
• Hands-on experience supporting FDA inspections, ideally in both front-room and back-room activities
• Strong GMP and quality systems knowledge
• CDMO experience strongly preferred
• Bachelor's degree in a relevant scientific discipline