Director of Quality Assurance Leadership

3 weeks ago


Reston, Virginia, United States G&L Healthcare Advisors Full time

Senior Director of Quality Assurance

Job Overview: G&L Healthcare Advisors is seeking a seasoned Senior Director of Quality Assurance to spearhead our client's quality transformation initiative. This role requires a seasoned professional with deep expertise in GMP and experience in manufacturing plants within the pharma or CMO industry.

Key Responsibilities:

  • Lead and manage the client's quality remediation efforts, addressing existing issues and ensuring progress on new items added weekly.
  • Oversee the implementation of a modern, compliant Quality Management System (QMS) and manage quality processes such as deviations, investigations, change controls, and Corrective Action Preventive Action (CAPA).
  • Partner with the project lead to drive quality improvements across US sites, with plans to expand internationally.
  • Manage inspections, audits, and regulatory interactions, ensuring compliance with FDA requirements and mitigating the risk of warning letters.
  • Collaborate with other leaders to foster a culture of quality and continuous improvement, emphasizing data integrity and modern practices.

Qualifications:

  • 15+ years of experience in QA with a deep understanding of GMP in the pharma or CMO industry.
  • Proven ability to lead quality transformations in a manufacturing environment.
  • Experience in handling large-scale remediation efforts and familiarity with quality processes from deviations to root cause analysis.
  • Strong leadership skills to manage resistance and cultural shifts, especially in an organization transitioning from long-standing practices.
  • Ability to work closely with senior leaders to drive quality changes under tight deadlines.


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