QA Compliance, Manager

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.