QA Compliance, Manager

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

Description

JOB DUTIES & RESPONSIBILITIES

• Lead and guide cGMP Compliance efforts at the Chantilly site, ensuring alignment with applicable regulations.
• Possess expert knowledge of 21CFR, ICH, and USP to effectively interpret and apply regulations in addressing cGMP Operations-related queries at the Chantilly site.
• Serve as the site’s Quality representative during FDA inspections.
• Assist in inspections by external regulators and business partners.
• Conduct Compliance GAP analyses, providing recommendations for gap closure, implementation, and follow-up effectiveness checks.
• Develop and execute site-wide remediation and improvement plans based on Quality metrics assessments.
• Maintain and analyze Quality metrics for the site to ensure continued Compliance.
• Build and manage systems, processes, and cross-functional teams to oversee Compliance at the site.
• Manage and support direct reports by establishing clear expectations and resolving conflicts.
• Ensure adherence to company procedures and resolve deviations from procedures or cGMP requirements promptly.
• Collaborate with various departments on quality issues, audits, and special projects.
• Offer guidance to manufacturing teams on Quality cGMP issues, ensuring compliance with applicable standards and regulations in coordination with the Site QA team.
• Provide technical expertise in deviations, CAPA, Root Cause Assessments, cGMP compliance, and data trending.
• Review and approve protocols, SOPs, and investigations.
• Oversee and supervise the collection of data for product review.
• Prepare and review documentation required for regulatory submissions, as needed.
• Participate in the Quality Task Force and contribute to the development and review of company standard operating procedures.
• Ensure the site stays up to date with all changes to applicable compendia, regulations, and guidance.

Requirements

Responsibility includes training and developing direct reports to keep abreast of current technology as it relates to cGMP Compliance.