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.