cGMP Compliance Leader — FDA Readiness & QA

Granules Pharmaceuticals; Chantilly (VA); On-site; USD 120,000 - 180,000; Full time

Job summary

Granules Pharmaceuticals in Chantilly, VA, seeks a senior quality leader to drive cGMP compliance across the site. You will apply 21 CFR, ICH, and USP standards to interpret regulations and address compliance questions within cGMP operations.

As the site Quality representative during FDA inspections, you will guide cross-functional teams, develop remediation plans, and ensure timely closure of gaps while maintaining robust quality metrics for continuous improvement.

Qualifications

• Proven knowledge of cGMP, 21 CFR, ICH and USP regulations.
• Experience training teams on quality systems and compliance.
• Ability to interpret complex regulations and apply them to manufacturing operations.

Responsibilities

• Lead and guide cGMP compliance efforts at the Chantilly site.
• Serve as the site’s Quality representative during FDA inspections.
• Develop remediation plans and monitor implementation for quality improvements.
• Maintain and analyze site quality metrics to ensure ongoing compliance.
• Review protocols, SOPs, investigations, and regulatory submissions.

Skills

cGMP Compliance

21 CFR knowledge

ICH knowledge

CAPA

Root Cause Analysis

FDA inspections

Job description

Granules Pharmaceuticals in Chantilly, VA, seeks a senior quality leader to drive cGMP compliance across the site. You will apply 21 CFR, ICH, and USP standards to interpret regulations and address compliance questions within cGMP operations.

As the site Quality representative during FDA inspections, you will guide cross-functional teams, develop remediation plans, and ensure timely closure of gaps while maintaining robust quality metrics for continuous improvement.