cGMP Compliance Leader — FDA Readiness & QA Oversight

Granules Pharmaceuticals, Inc.; Chantilly (VA); On-site; USD 90,000 - 100,000; Full time

Job summary

Granules Pharmaceuticals, Inc. in Chantilly seeks a Lead cGMP Compliance Leader to guide the site’s quality program and ensure adherence to 21 CFR, ICH, and USP standards.

You will serve as the site QA representative during FDA inspections, collaborate cross-functionally, and develop remediation plans using quality metrics. The role also involves training direct reports and driving CAPA, deviations, and investigations to closure.

Qualifications

• Extensive knowledge of cGMP regulations and quality systems.
• Ability to interpret 21 CFR, ICH, and USP.
• Experience serving as QA representative during FDA inspections.
• Proven capability in CAPA, deviations, and root cause analyses.
• Strong data trending and metrics analysis skills.

Responsibilities

• Lead cGMP compliance efforts at the Chantilly site.
• Serve as the site QA representative during FDA inspections.
• Support inspections by external regulators and business partners.
• Conduct Compliance GAP analyses and drive closure actions.
• Develop site-wide remediation plans based on quality metrics.
• Maintain and analyze quality metrics to ensure ongoing compliance.
• Build and manage systems, processes, and cross-functional teams for site compliance.
• Oversee data collection for product review and regulatory submissions.

Skills

cGMP compliance

FDA inspections

CAPA & root cause

Regulatory interpretation

Data trending & metrics

Leadership & coaching

Job description

Granules Pharmaceuticals, Inc. in Chantilly seeks a Lead cGMP Compliance Leader to guide the site’s quality program and ensure adherence to 21 CFR, ICH, and USP standards.

You will serve as the site QA representative during FDA inspections, collaborate cross-functionally, and develop remediation plans using quality metrics. The role also involves training direct reports and driving CAPA, deviations, and investigations to closure.