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Granules Pharmaceuticals

QA Compliance, Manager

Granules Pharmaceuticals Chantilly, Virginia, United States · $90K–$100K/yr

Pharmaceutical Manufacturing · 201-500 employees

18 m ago
qa Senior (5-10 yrs) Full-time United States
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About the role

The manager will lead cGMP compliance efforts at the Chantilly site, serving as the primary quality representative during FDA inspections. They are responsible for managing quality systems, overseeing cross-functional teams, and ensuring all site operations adhere to regulatory standards.

What they look for

Cgmp Compliance 21CFR ICH USP FDA Inspections Gap Analysis Quality Metrics Remediation Planning Deviations CAPA Root Cause Assessment Data Trending SOP Development Regulatory Submissions Team Leadership Quality Assurance

Requirements

The role requires expert knowledge of 21CFR, ICH, and USP regulations to interpret and apply compliance standards effectively. Candidates must possess the ability to lead remediation plans, conduct gap analyses, and provide technical expertise in CAPA and deviation investigations.

Full description

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.

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