QA Compliance, Manager

Granules•Chantilly, VA

About The Position

The QA Compliance Manager will lead and guide cGMP Compliance efforts at the Chantilly site, ensuring alignment with applicable regulations. This role requires expert knowledge of 21CFR, ICH, and USP to effectively interpret and apply regulations in addressing cGMP Operations-related queries. The manager will serve as the site’s Quality representative during FDA inspections and assist with inspections by external regulators and business partners. Responsibilities include conducting Compliance GAP analyses, developing and executing site-wide remediation and improvement plans, and maintaining Quality metrics for the site. The role involves building and managing systems, processes, and cross-functional teams to oversee Compliance, as well as managing and supporting direct reports. The manager will ensure adherence to company procedures, resolve deviations, and collaborate with various departments on quality issues, audits, and special projects. Additionally, the position offers guidance to manufacturing teams on Quality cGMP issues and provides technical expertise in deviations, CAPA, Root Cause Assessments, cGMP compliance, and data trending. The role also includes reviewing and approving protocols, SOPs, and investigations, overseeing data collection for product review, and preparing documentation for regulatory submissions. Participation in the Quality Task Force and the development/review of company standard operating procedures is expected. The manager must ensure the site stays up to date with all changes to applicable compendia, regulations, and guidance. Training and developing direct reports on current technology related to cGMP Compliance is also a key responsibility.

Requirements

Expert knowledge of 21CFR, ICH, and USP.
Ability to interpret and apply regulations in addressing cGMP Operations-related queries.
Experience serving as a Quality representative during FDA inspections.
Experience assisting in inspections by external regulators and business partners.
Experience conducting Compliance GAP analyses.
Experience developing and executing site-wide remediation and improvement plans.
Experience maintaining and analyzing Quality metrics.
Experience building and managing systems, processes, and cross-functional teams.
Experience managing and supporting direct reports.
Experience ensuring adherence to company procedures and resolving deviations.
Experience collaborating with various departments on quality issues, audits, and special projects.
Experience offering guidance to manufacturing teams on Quality cGMP issues.
Experience providing technical expertise in deviations, CAPA, Root Cause Assessments, cGMP compliance, and data trending.
Experience reviewing and approving protocols, SOPs, and investigations.
Experience overseeing and supervising the collection of data for product review.
Experience preparing and reviewing documentation required for regulatory submissions.
Experience participating in the Quality Task Force.
Experience contributing to the development and review of company standard operating procedures.
Knowledge of current technology as it relates to cGMP Compliance.

Responsibilities

Lead and guide cGMP Compliance efforts at the Chantilly site, ensuring alignment with applicable regulations.
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.
Train and develop direct reports to keep abreast of current technology as it relates to cGMP Compliance.