QA Compliance, Manager

Smart Media; Chantilly (VA); On-site; USD 130,000 - 180,000; Full time

Job summary

Smart Media seeks a senior Quality Compliance lead at its Chantilly, VA site to steer cGMP programs in alignment with 21CFR, ICH and USP standards. The role requires guiding cross‑functional teams, enabling effective regulatory submissions, and serving as the site Quality representative during FDA inspections.

You will build systems, monitor quality metrics, manage a team of direct reports, and drive remediation plans to ensure ongoing compliance across all site operations.

Qualifications

• Lead cGMP compliance efforts and guide cross-functional teams.
• Interpret and apply 21CFR, ICH, and USP regulations.
• FDA inspections: serve as site Quality representative.
• Regulatory submissions support and CAPA/Root Cause expertise.

Responsibilities

• Lead cGMP compliance efforts at the Chantilly site, ensuring alignment with applicable regulations.
• Possess expert knowledge of 21CFR, ICH, and USP to interpret and apply regulations for cGMP operations.
• Serve as the site's Quality representative during FDA inspections.
• Assist in inspections by external regulators and business partners.
• Conduct Compliance GAP analyses and provide gap closure recommendations.
• Develop and execute site-wide remediation and improvement plans based on Quality metrics.
• 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 cGMP promptly.
• Collaborate with departments on quality issues, audits, and projects.
• Provide guidance to manufacturing teams on Quality cGMP issues with Site QA.
• Review deviations, CAPA, Root Cause Assessments, and data trending.
• Review and approve protocols, SOPs, and investigations.
• Oversee data collection for product review and regulatory submissions as needed.
• Participate in the Quality Task Force and SOP development.
• Stay current with changes to compendia, regulations, and guidance.

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.