QA Compliance, Manager

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

• 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.

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.

Salary Description

$90,000.00 - $100,000.00/ Yearly